Clinical Trials

The purpose of this study is to utilize liver allografts from HCV seropositive donors into 10 HCV seronegative recipients. 

This is an efficacy and safety study of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) with or without ribavirin (RBV) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infections who have failed prior therapy with pegylated interferon and RBV. The primary study hypothesis is that in at least one of the study arms, the percentage of participants achieving sustained viral response 12 weeks after the end of all study treatment (SVR12) will be superior to 58%.

The purpose of this study, is to open expanded access at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Patients who have an aggressive, recurring hepatitis C infection following liver transplant, will be given sofosbuvir combined with ribavirin, and pegylated interferon may or may not be added at the discretion of the investigator.

The purpose of this study is to evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Participants will be randomized to receive 12 or 24 weeks of dosing with the LDV/SOF FDC tablet+ribavirin (RBV).

The purpose of this study is to measure the rates of continuing viral presence, following anti-viral therapy with combined Peg-Interferon and Ribavirin in patients that have had a liver transplant, are immune suppressed with Neoral or tacrolimus, and have a recurring infection with the Hepatitis C virus.

The purpose of this study is to determine whether INO-8000 alone or in combination with INO-9012 (IL-12) is safe and induces a Hepatitis C virus-specific immune response.

The purpose of this study is to evaluate the safety and efficacy of ABT-493 and ABT-530 (or ABT-493/ABT-530) coadministered with and without ribavirin in adults with chronic HCV genotypes 2, 3, 4, 5 or 6 infection. In part 4, the primary objectives also include to assess the efficacy (SVR12) of treatment with ABT-493/ABT-530 combination regimen in GT2-infected DAA-naive subjects without cirrhosis compared to historical SVR12 rate of treatment with sofosbuvir plus RBV in GT2-infected DAA-naive subjects without cirrhosis.

This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

The primary purpose of the HCV-TARGET study is to establish a nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C (HCV) at both academic and community practices.

The purpose of this study is to:

1. To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with DAA, and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic

2. To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the HCV genotype

3. To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy ...

The purpose of this study is to compare the safety and effectiveness of using ABT-493/ABT-530, to the combination of sofosbuvir and daclatasvir in treating adults with genotype 3 chronic hepatitis C virus infection.

The purpose of this study is to evaluate clinical experience with donor screening for fecal transplant, and to evaluate the outcomes from fecal transplant and understand risk factors for fecal transplant failure and relapse after fecal transplant.

The purpose of this study is to better understand the role of HIV and/or HCV infection and/or SARS-CoV-2 on the immune system and potential ways to eliminate the virus(es).

The purpose of this open-label extension of CDI-001 (subsequently referred to as PRISM 3) is to evaluate the safety and efficacy in reducing recurrence of CDI in adults who had a recurrence within 8 weeks of receiving CP101 or placebo in PRISM 3. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in the extension study and administered CP101. Approximately 70 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The ...

The purpose of this registry is to enroll patients who have cirrhosis with a sustained viral response after receiving a sofosbuvir-based treatment without interferon, either while participating in a Gilead-sponsored hepatitis C virus study or commercially at selected sites. Once enrolled, the patients will be followed for up to 5 years.

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

608 patients with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study and receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

The purpose of this study is to evaluate the safety and effectiveness of CP101 treatment in adults who had a Clostridum difficile Infection (CDI) recurrence within 8 weeks of receiving CP101 or placebo.

The purpose of this study is to evaluate if Vancomycin Resistant Enterococci (VRE) can be eradicated in patients with Clostridium Difficile infection (CDI) through treatment with Fecal Microbiota Transplantation (FMT) when FMT is being done to treat recurrent CDI rather than VRE.

The primary objective of this program is to provide Daclatasvir (DCV) for 24 weeks to be given in combination with Sofosbuvir (SOF) to post-liver transplant subjects with chronic hepatitis C recurrence and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to < 12 months, including advanced fibrosis or fibrosing cholestatic hepatitis.This protocol will be opened at specific clinical sites for the treatment of individual subjects for whom there are no other treatment options and will allow for the collection of safety and efficacy data.

This study will assess the safety of a new biologic drug, RBX2660 (microbiota suspension) as a treatment for recurrent Clostridium difficile-associated diarrhea (CDAD), which is the primary symptom of recurrent Clostridium difficile infection. All eligible subjects will receive RBX2660.

Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-012.

The purpose of the study is to ascertain the efficacy of implementation of standard treatment guidelines for the treatment of C. difficile infection based on disease severity and number of instances of this infection.

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

The primary purpose of the study is to establish a long-term nationwide registry of patients undergoing treatment with antiviral therapies for chronic hepatitis C  at academic and community practices.

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.

This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.

The purpose of this study is to develop an advanced multiparametric liver magnetic resonance elastography (MRE) imaging technology for monitoring hepatic inflammation during direct acting antiviral (DAA) treatment, evaluation risks of severe liver injury, and HCC development.

This study is to see if PCR test developed at Mayo Clinic to diagnosis C. Difficile infections is able to predict the risk of recurrent infection.

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/GS-5816 FDC for 24 weeks in adults with hepatitis C virus (HCV) infection and Child-Pugh (CPT) class B cirrhosis.

The purpose of this study is to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient. Both drugs are FDA-approved. Mavyret™ is currently used commercially to treat Hepatitis C and Zetia® is used commercially to treat high cholesterol.

This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.

The purpose of this study will evaluate the safety and effectiveness of VE303 for participants with recurrent Clostridium difficile infection (rCDI).

The primary goal of this study will be to assess whether stool collected and frozen from anonymous screened unrelated donors can be as effective as stool freshly collected from recipient's parents when used in Fecal Microbial Transplant for the eradication of recurrent Clostridium difficile infections in children. In the current protocols, which are more than 90% effective, each child who is receiving a fecal transplant has to provide their own donor stool, usually from a parent or close relative. This requires considerable screening costs for each case and is logistically complicated as the donor must be present and must stool ...

This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum Microbiota® (CP101) in Subjects with Recurrence of Clostridium difficile Infection (PRISM3)

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in subjects with recurrence of Clostridium difficile infection.

A Phase 3b, single arm, open-label, multicenter study to evaluate the safety and to demonstrate the non-inferiority of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with the glecaprevir (GLE)/pibrentasvir (PIB) combination regimen to the historical SVR12 rate of 12 weeks of treatment with the GLE/PIB in treatment-naïve adults with chronic HCV GT 1, 2, 4, 5, or 6 infection and compensated cirrhosis.

The primary objectives of this study are to evaluate the pharmacokinetics (PK), safety, and tolerability of bezlotoxumab in children aged 1 to <18 years of age with a confirmed diagnosis of Clostridium difficile infection (CDI) who are receiving antibacterial drug treatment. The primary hypothesis is that the area under the concentration-time curve from 0 to infinity (AUC0-inf) of bezlotoxumab after treatment of pediatric participants with bezlotoxumab is similar when compared to the AUC0-inf of bezlotoxumab after treatment of adults with bezlotoxumab,

The purpose of this study is to estimate the success, recurrence, and complications over the 90 day follow up period for the treatment of C. difficile infection in adult solid organ or stem cell transplant patients.

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults with Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis.

The purpose of this trial is to examine the effect of Fecal Microbiota Transplantation (FMT) compared with Vancomycin for cure of recurrent C. diff infection (CDI) in solid organ transplant (SOT) recipients in a randomized, controlled clinical trial.

This study will evaluate efficacy and safety information about RBX2660 for the treatment of recurrent Clostridium difficile infection (CDI). Enrolled subjects will receive one treatment with RBX2660 (microbiota suspension).

To assess the safety and tolerability of RBX2660 in subjects with recurrent CDI who have had prior recurrent CDI that was resolved with antibiotic treatment.

The purpose of this trial is to evaluate the effectiveness, safety, and tolerability of a single oral administration of study drug CP101 for the prevention of recurrent Clostridioides difficile Infection (CDI) in adult patients.

This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm (Part A) and an optional open-label treatment arm (Part B). After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized to receive either the study drug CP101 or placebo in Part A of the trial.  Patients will be evaluated for CDI recurrence and safety ...

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least two recurrences after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization within the last year may be eligible for the study. Subjects who are deemed failures following the blinded treatment per the pre-specified treatment failure definition may elect to receive an unblinded RBX2660 enema.

The purpose of this study is to evaluate microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of Clostridium Difficile Infection (CDI) after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

The purpose of this research is to evaluate the primary objectives of safety and effectiveness (rate of clinical cure) of 2 dosages of CRS3123 (200 mg and 400 mg) administered orally (po) twice daily (bid) and vancomycin administered 125 mg PO 4 times daily (qid) in adults > or equal to 18 years of age with a primary episode or first recurrence of CDI. The study will investigate the plasma concentrations and HRQoL outcomes of CRS3123 and additional efficacy endpoints as secondary objectives.

The purpose of this study is to confirm the effectiveness of RBX2660 as compared to a placebo in preventing recurrent episodes of Clostridium difficile Infection (CDI) through 8 weeks.

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

The purpose of this study is to evaluate the safety and tolerability of ART24 after 7 or 28 days of daily administration in recently-cured C. diff infection subjects.

This study evaluates the efficacy of prophylaxis with oral vancomycin for preventing recurrent Clostridium difficile Infection (CDI) in patients who have experienced at least one CDI episode in the last 180 days and are receiving antibiotics for a non CDI condition. Participants will be randomized to receive either placebo or oral vancomycin in addition to their prescribed antibiotic therapy.

The purpose of this study is to demonstrate the efficacy and safety of RBX7455 (an oral microbiota based drug) for the treatment of recurrent clostridium difficile infection (CDI) in subjects who have had at least one recurrence after a primary episode (i.e., at least two episodes) and have completed at least two rounds of standard-of-care oral antibiotic therapy. Study subjects will have their diarrhea resolved, i.e., would be having less than 3 watery bowel movements at the time of study enrollment for 48 hours or more.

The purpose of this study is to extend the previous SERES-004 study in patients who had a recurrence of clostridium difficile infection within the first 8 weeks of participation.  

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24 week regimen of ombitasvir/ABT-450/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30, including those on hemodialysis.

The purpose of this study is to evaluate the safety and effectiveness of VE303 for participants with primary C. difficile infection (pCDI) at high risk for recurrence or subjects with recurrent C. difficile infections (rCDI).

The purpose of this study is to compare ridinilazole with vancomycin as comparator to treat Clostridium difficile Infection (CDI) with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease.

The purpose of this study is to assess patients suspected of recurrent C. difficile disease (rCDI) and using a combination of clinical and laboratory markers to determine disease versus post infectious irritable bowel syndrome (IBS) with C. difficile colonization.

The purpose of this study is to find the rate of Hepatitis B, Hepatitis C, and Hepatocellular Carcinoma in individual populations of African descendants living in Minnesota, and to see what the current knowledge, attitudes and practices of these immigrants are towards screening, vaccination, and disease management.

The purpose of this study is to characterize the mucosal microbiome in patients who have recently been treated for Clostridium-difficile Infection (CDI) in comparison to that of control population to determine the effect of the mucosal associated microbiome on outcome of CDI.

 

The purpose of this study is to characterize mucosal and luminal microbiome in patients diagnosed with Clostridium difficile infection (CDI), at the time of diagnosis and after treatment, to determine the effect of mucosa associated microbiome on outcome of CDI and the effect of antibiotic treatment on mucosa associated microbiome

The microbiome within the gut lumen has been found in prior studies to differ in individuals with C. difficile infection (CDI) in comparison to those without diarrhea. The microbiome associated with the mucosal surface on the colon has been noted to differ from that of the lumen in other clinical scenarios, although this has not been studied in depth in patients with CDI. The goal of this research is to characterize the mucosal microbiome in patients with CDI after treatment to characterize this microbiome and determine the effect on recurrence of CDI.

The purose of this study is to assess the effectiveness, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

The purpose of this study is to assess short- and long-term clinical outcomes and immune responses after SARS-CoV-2 infection and/or MIS-C in children (defined as individuals who have not yet reached their 21st birthday).  Participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of SARS-CoV-2 positive children. 

The purpose of this study is to establish the Maximum Tolerated Dose (MTD), assess the safety, tolerability, and pharmacokinetics of subcutaneous PHIN-214 in participants with compensated and decompensated cirrhosis. In addition, various exploratory markers of effectiveness will be analyzed. 

We purpose of this study is to evaluate the diagnosis accuracy of the Controlled Attenuation Parameter (CAP) measured by FibroScan® (both with M and XL probes) in all patients who are undergoing liver biopsy for any liver disease.