Clinical trials: HEPATITIS C VIRUS CHRONIC INFECTION
Hepatitis C
Double Filtration Plasmapheresis for Hepatitis C Virus (HCV) Genotype 1 Patients With High Viral Load
Hepatitis C virus (HCV) infection, a leading cause of cirrhosis, hepatocellular carcinoma (HCC) and liver transplantation, affects approximately 170 million individuals worldwide.
- Trial name
- NCT00977054
- Testing
- DFPP + Peg-IFN + RBV, Peg-IFN + RBV
- Where
- 6 sites in Taiwan
- Volunteers
- 59 people
- Sponsor
- National Taiwan University Hospital
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Hepatitis C, Chronic
HELPS Study - A Study of Peginterferon Alfa-2a (Pegasys) in Patients With Chronic Hepatitis C (CHC) and End-Stage Renal Disease (ESRD)
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
- Trial name
- NCT02806505
- Testing
- Peginterferon alfa-2a
- Where
- 22 sites in Austria, Brazil and 6 more
- Volunteers
- 81 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Relative Bioavailability Study of Ribavirin 200 Capsules and Rebetol 200 mg Capsules in Females Under Fasting Conditions
The purpose of this study is to demonstrate the relative bioavailability of Ribavirin 200 capsules and Rebetol 200 mg capsules in females under fasting conditions.
- Trial name
- NCT00960479
- Testing
- Ribavirin 200 mg Oral Capsule (Geneva Pharmaceutical, U.S.A.), Rebetol 200 mg Oral Capsule (Schering Corporation, U.S.A.)
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Sandoz
Hepatitis C
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742)…
- Trial name
- NCT02251990
- Testing
- Grazoprevir/Elbasvir
- Volunteers
- 489 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Evaluation of Satisfaction in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C (Study P04067)
The current gold standard for treatment of chronic hepatitis C (CHC) patients is with pegylated interferon plus ribavirin. Drug administration accuracy and ease of use will definitely determine treatment effectiveness.
- Trial name
- SATISFACTION (NCT00727259)
- Testing
- Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908)
- Volunteers
- 1,995 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C Virus Infection, Genotype 1
A Phase I/II Clinical Trial With Interferon Alfa 5 in Treatment-Experienced Patients With Genotype-1 Chronic Hepatitis C
The general aim of this study is to determine if 3 MIU of IFN-α5 in monotherapy, and 1,5 MIU of IFN-α5 combined with 1,5 MIU of IFN- α2b, are safe dose levels as well as to investigate the antiviral efficacy and pharmacodynamics…
- Conditions
- Chronic Hepatitis C Virus Infection, Genotype 1, Treatment-Experienced Patients, Relapses
- Trial name
- NCT01121731
- Testing
- Interferon α-5, Interferon-α5 plus Interferon-α 2b, Interferon α-2b (INTRON® A)
- Where
- 15 sites in Spain
- Volunteers
- 70 people
- Sponsor
- Digna Biotech S.L.
Hepatitis C Virus Infection
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
The primary objective of this study is to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and ribavirin (RBV) in participants with chronic…
- Trial name
- NCT02822794
- Testing
- SOF/VEL, RBV
- Where
- 18 sites in Japan
- Volunteers
- 117 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with…
- Trial name
- NCT01628094
- Testing
- RO5024048, RO5190591, RO5466731
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C
The interferon-free combination regimen of paritaprevir/ritonavir/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
- NCT02725866
- Testing
- Paritaprevir/ritonavir/ombitasvir, Dasabuvir, Ribavirin
- Volunteers
- 216 people
- Sponsor
- AbbVie
Hepatitis C, Chronic, Human Immunodeficiency Virus
Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients
The purpose of this study is to evaluate the efficacy and tolerability of DAA-based regimens in the clinical practice in HIV/HCV-coinfected patients.
- Trial name
- NCT02057003
- Testing
- DAA against HCV
- Where
- Spain
- Volunteers
- 1,000 people
- Sponsor
- Valme University Hospital
Hepatitis C
Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects
This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in…
- Trial name
- INH-189-006 (NCT01445795)
- Testing
- 200 mg INX-08189 Fasted, 100 mg INX-08189 QD, 100 mg INX-08189 with low-fat meal
- Where
- 2 sites in United States, Puerto Rico
- Volunteers
- 50 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Chronic, Liver Cirrhosis
Efficacy and Safety of Peginterferon Alfa-2b and Ribavirin Therapy in Subjects With Type C Compensated Liver Cirrhosis (Study P05116)
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C…
- Trial name
- NCT00687219
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 102 people
- Sponsor
- Merck Sharp & Dohme LLC
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Chronic Hepatitis C
Clinical Pharmacology Study of MP-424
To conduct the following evaluations in Korean healthy male adult volunteers receiving a single and multiple doses of MP-424 tablets: Pharmacokinetics of MP-424 after a single and multiple doses.
- Trial name
- NCT01766167
- Testing
- MP-424
- Where
- South Korea
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Renal Impairment, End-stage Renal Disease
An Efficacy, Safety, Tolerability and Pharmacokinetics Study of 12 Weeks Treatment With Simeprevir and Daclatasvir in Participants With Chronic Hepatitis C Virus Genotype 1b or 4 Infection and Either Severe Renal Impairment or End-stage Renal Disease on Hemodialysis.
The purpose of this study is to evaluate the percentage of participants with sustained virologic response 12 weeks after the actual end of study treatment (SVR12)
- Trial name
- NCT02397395
- Testing
- Simeprevir (SMV) 150 mg, Daclatasvir (DCV) 60 mg
- Where
- 6 sites in France, Spain
- Sponsor
- Janssen R&D Ireland
Hepatitis C, Chronic
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus…
- Trial name
- NCT00394277
- Testing
- peginterferon alfa-2a, Ribavirin
- Where
- 184 sites in United States, Belgium and 13 more
- Volunteers
- 1,175 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
Peginterferon Alfa-2a, Ribavirin, Amantadine/Placebo in Hepatitis C Virus (HCV)-Genotype-1-Infection (PRAMA)
This was a randomized, multi-center, partially placebo-controlled Phase IV study to compare the efficacy and tolerability of a 48-week combined therapy with pegylated interferon alpha-2a, ribavirin and amantadine sulphate versus…
- Trial name
- NCT00127777
- Testing
- Amantadine sulphate (in addition to standard treatment)
- Volunteers
- 700 people
- Sponsor
- University Hospital, Saarland
Hepatitis C Virus Infection
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with…
- Trial name
- NCT02114151
- Testing
- Simeprevir, Sofosbuvir
- Where
- 34 sites in United States, Canada
- Volunteers
- 103 people
- Sponsor
- Janssen Infectious Diseases BVBA
Chronic Hepatitis C
Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection
The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
- Trial name
- NCT01826981
- Testing
- LDV/SOF, SOF, RBV
- Where
- 2 sites in New Zealand
- Volunteers
- 359 people
- Sponsor
- Gilead Sciences
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