Clinical trials: HCV
Hepatitis C
A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients
The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not…
- Trial name
- COSMOS (NCT01466790)
- Testing
- TMC435, PSI-7977 (GS7977), Ribavirin
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 168 people
- Sponsor
- Janssen R&D Ireland
Hepatitis C, Chronic Kidney Disease
Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD)
Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD) who are treated with Harvoni for 12 weeks have improvements in their kidney disease.
- Trial name
- NCT02503735
- Testing
- Sofosbuvir/Ledipasvir FDC
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Massachusetts General Hospital
Chronic Hepatitis C Infection
A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C
The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as…
- Trial name
- PEARL-II (NCT01674725)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin
- Volunteers
- 187 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C, Chronic
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C…
- Trial name
- DRAGON (NCT00996476)
- Testing
- TMC435, PegIFNα-2a, RBV
- Where
- 19 sites in Japan
- Volunteers
- 92 people
- Sponsor
- Janssen Pharmaceutical K.K.
Hepatitis C, Chronic
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C…
- Trial name
- PEARL-I (NCT01685203)
- Testing
- ABT-450/r, ABT-267, Ribavirin (RBV)
- Volunteers
- 316 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Liver Transplant Recipient
Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients
The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients.
- Trial name
- NCT01150097
- Testing
- Tacrolimus (reduced tacrolimus), Everolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination)
- Where
- 57 sites in United States, Argentina and 14 more
- Volunteers
- 284 people
- Sponsor
- Novartis Pharmaceuticals
Genotype 1 Chronic Hepatitis C, Treatment Naive
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1…
- Trial name
- NCT01241760
- Testing
- Ribavirin, Telaprevir, Pegylated interferon alfa-2a
- Where
- 99 sites in United States, Australia and 11 more
- Volunteers
- 744 people
- Sponsor
- Janssen Infectious Diseases BVBA
Hepatitis C, Hemodialysis
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
This is a study to define strategies for Nephrologists to directly supervise and apply direct acting antivirals to cure hepatitis C in hemodialysis patients.
- Conditions
- Hepatitis C, Hemodialysis, Nosocomial Infection
- Trial name
- HD (NCT03365635)
- Testing
- Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Pennsylvania
Medication Adherence, Substance Abuse, Intravenous
A Randomized Trial of Vaccine Adherence in Young Injection Drug Users
The purpose of this study is to compare the effects of (a) immunization setting and (b) outreach worker support on young injection drug users' (IDU) adherence to a multiple dose immunization schedule with a combined hepatitis A…
- Conditions
- Medication Adherence, Substance Abuse, Intravenous, Risk Behavior, Hepatitis A
- Trial name
- UFO VAX (NCT00244374)
- Testing
- Hepatitis A & B vaccine, Outreach, AIC
- Where
- United States
- Volunteers
- 546 people
- Sponsor
- University of California, San Francisco
Chronic Hepatitis C Infection
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV)…
- Trial name
- NCT01260350
- Testing
- SOF, RBV, PEG
- Where
- 2 sites in New Zealand
- Volunteers
- 292 people
- Sponsor
- Gilead Sciences
Hepatitis C
Safety, Tolerability, and Antiviral Activity of ACH-0141625 or Placebo in Combination With Peginterferon and Ribavirin in Hepatitis C Virus (HCV) Positive Participants
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.
- Trial name
- NCT01180790
- Testing
- ACH-0141625 (Sovaprevir), Pegylated Interferon alpha-2a, Ribavirin
- Where
- 18 sites in United States, Belgium
- Volunteers
- 122 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Hepatitis C Infection
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
- Trial name
- MALACHITE 1 (NCT01854697)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin, Telaprevir
- Volunteers
- 311 people
- Sponsor
- AbbVie
Hepatitis C, Chronic
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease
The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent…
- Trial name
- NCT00516321
- Testing
- eltrombopag
- Where
- 191 sites in United States, Australia and 23 more
- Volunteers
- 687 people
- Sponsor
- GlaxoSmithKline
Hepatitis C, Liver Disease
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination…
- Trial name
- NCT02094443
- Testing
- Alisporivir, Ribavirin
- Where
- 16 sites in United States, France
- Volunteers
- 52 people
- Sponsor
- Debiopharm International SA
Hepatitis C
Cerebral Effects of Pegylated Interferon in Hepatitis C Positive Subjects
The hypothesis of this study is that pegylated interferon would cause cognitive deficits and mood changes in hepatitis C (HCV) positive subjects.
- Trial name
- NCT00136214
- Testing
- MR brain and neuropsychiatric tests
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Beth Israel Deaconess Medical Center
Chronic Hepatitis C
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in…
- Trial name
- NCT02798315
- Volunteers
- 40 people
- Sponsor
- AbbVie
Hepatitis C, Liver Cirrhosis
Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis
This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (< 7 points).
- Trial name
- NCT01909778
- Testing
- BI 201335
- Where
- Germany
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus…
- Trial name
- NCT02413593
- Testing
- LDV/SOF, RBV
- Where
- 15 sites in Canada
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences
Hepatitis C
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic…
- Trial name
- NCT01909804
- Testing
- SOF, VEL, RBV
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 323 people
- Sponsor
- Gilead Sciences
Hepatitis C
eHealth Partnered Evaluation Initiative - Evaluation of the Initial Deployment of VA's Annie Texting System
Conduct a rigorous formative evaluation of the initial deployment of the Annie texting system across several pilot test sites and from these findings, develop and test an augmented implementation strategy to facilitate more rapid…
- Trial name
- AnnieEval (NCT03898349)
- Testing
- Annie text messaging system, Annie text messaging system with Usual implementation, Annie text messaging system with Augmented implementation
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- VA Office of Research and Development