Clinical trials: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in adults with chronic…
- Trial name
- NCT02472886
- Testing
- LDV/SOF, RBV
- Where
- 20 sites in Estonia, Russia
- Volunteers
- 153 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
A Pharmacokinetics/Pharmacodynamics Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104AM2)(COMPLETED)
SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC), peginterferon-alfa plus ribavirin, would…
- Trial name
- NEXT-1 (NCT00797745)
- Testing
- peginterferon alfa 2b, ribavirin, SCH 900518
- Volunteers
- 111 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection
This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to…
- Trial name
- NCT00192647
- Testing
- PEG-IFN alfa-2a, Ribavirin
- Where
- 51 sites in Argentina, Australia and 4 more
- Volunteers
- 896 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C Virus
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in…
- Trial name
- NCT01726517
- Testing
- LDV/SOF, RBV
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.
This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus…
- Trial name
- NCT00412334
- Testing
- Copegus, peginterferon alfa-2a [Pegasys]
- Where
- 22 sites in France
- Volunteers
- 104 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3.
- Trial name
- NCT01033448
- Testing
- COPEGUS, peginterferon alfa-2a [Pegasys]
- Where
- 20 sites in Israel
- Volunteers
- 59 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus (HCV)
Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human…
- Trial name
- VOYAGE-2 (NCT03235349)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 34 sites in China, South Korea
- Volunteers
- 160 people
- Sponsor
- AbbVie
Hepatitis C Virus
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with…
- Trial name
- HEPCAT (NCT01170962)
- Testing
- BMS-790052, peginterferon alfa-2a, ribavirin
- Where
- 72 sites in United States, Argentina and 9 more
- Volunteers
- 512 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis
To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.
- Trial name
- NCT01973049
- Testing
- Daclatasvir, Asunaprevir, BMS-791325
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 202 people
- Sponsor
- Bristol-Myers Squibb
Genotype 1 Chronic Hepatitis C
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in…
- Trial name
- NCT01498068
- Testing
- Telaprevir, Pegylated-interferon-alfa-2a, Ribavirin
- Where
- 5 sites in Russia
- Volunteers
- 36 people
- Sponsor
- Janssen-Cilag International NV
Hepatitis C
A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).
- Trial name
- NCT00627926
- Testing
- Pegylated Interferon Alfa 2a, Telaprevir, Ribavirin
- Where
- 116 sites in United States, Argentina and 11 more
- Volunteers
- 1,095 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Chronic Hepatitis C
The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)
This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN…
- Trial name
- NCT01890200
- Testing
- Peginterferon alfa-2a, Ribavirin, TCM-700C
- Where
- 2 sites in China, Taiwan
- Sponsor
- TCM Biotech International Corp.
HCV
Long Term Extension Study is Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Long Term Observational Extension Study Designed to Monitor Long-Term Efficacy and Safety of Miravirsen Sodium in Combination with Telaprevir and Ribavirin in Subjects with Chronic Hepatitis C Virus Genotype 1 Infection
- Trial name
- NCT02452814
- Where
- 3 sites in United States, Puerto Rico
- Volunteers
- 8 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive…
- Trial name
- NCT02421211
- Testing
- Simeprevir (SMV), Ledipasvir (LDV), Sofosbuvir (SOF)
- Where
- 4 sites in Belgium
- Volunteers
- 41 people
- Sponsor
- Janssen Sciences Ireland UC
Hepatitis C Virus, HIV
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and…
- Trial name
- NCT02073656
- Testing
- LDV/SOF, RBV
- Where
- 41 sites in United States, Canada and 2 more
- Volunteers
- 335 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response…
- Trial name
- NCT02123654
- Testing
- Daclatasvir, Asunaprevir, DCV 3DAA
- Where
- 35 sites in Japan
- Volunteers
- 297 people
- Sponsor
- Bristol-Myers Squibb
HCV Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1…
- Trial name
- NCT01987453
- Testing
- LDV/SOF, RBV
- Where
- 43 sites in United States, Australia and 3 more
- Volunteers
- 100 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.
- Trial name
- STEADFAST (NCT01994486)
- Testing
- Telaprevir and Sofosbuvir
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Hepatitis C
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C…
- Trial name
- ASPIRE (NCT00980330)
- Testing
- TMC435, Peg-IFN-alfa-2a (P), Ribavirin (R)
- Where
- 78 sites in United States, Australia and 12 more
- Volunteers
- 463 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis C, Chronic, Hepatitis C
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C.
- Trial name
- NCT00724230
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 505 people
- Sponsor
- Merck Sharp & Dohme LLC