Clinical trials: Chronic Hepatitis C Infection
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus…
- Trial name
- NCT02249182
- Testing
- LDV/SOF, RBV
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 226 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic, Hepatitis C
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol.
- Trial name
- APEGIN (NCT00724854)
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 1,146 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 …
- Trial name
- MAGELLAN-3 (NCT02939989)
- Testing
- Sofosbuvir, Glecaprevir/Pibrentasvir, Ribavirin
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 33 people
- Sponsor
- AbbVie
Hepatitis C, Chronic, Hepatitis C
Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)
The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed…
- Trial name
- NCT00704717
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031) pen, Rebetol (ribavirin; SCH 18908)
- Volunteers
- 185 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
PegIntron Injection Surveillance Plan (Study P04123)
Surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis C are generally treated.
- Trial name
- NCT00723931
- Testing
- Peginterferon alfa-2b (SCH 54031)
- Volunteers
- 1,267 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
- Trial name
- FOURward (NCT02175966)
- Testing
- DCV/ASV/BMS-791325, Ribavirin, Sofosbuvir
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Chronic
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the…
- Trial name
- NCT00761735
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
- Trial name
- NCT01425190
- Testing
- Boceprevir
- Volunteers
- 16 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic, Hepatitis C
Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)
Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C.
- Trial name
- NCT00705107
- Testing
- PegIntron pen (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 267 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus (HCV)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in…
- Trial name
- DORA (NCT03067129)
- Testing
- Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 129 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
This study will have two parts as follows: The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric…
- Trial name
- NCT02175758
- Testing
- SOF, RBV
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric…
- Trial name
- NCT03820258
- Testing
- SOF/VEL/VOX
- Where
- 10 sites in Italy, Poland and 1 more
- Volunteers
- 21 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer…
- Trial name
- NCT02868242
- Testing
- LDV/SOF
- Where
- Egypt
- Volunteers
- 19 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C
The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.
- Trial name
- NCT00100659
- Testing
- Pegylated Interferon/ribavirin
- Where
- 11 sites in United States
- Volunteers
- 114 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis C, Chronic Disease
Hepatitis C Self-Management
The objective of this study is to compare the efficacy of a 6-session hepatitis C self-management workshop to a hepatitis C self-management self-study program.
- Trial name
- NCT00328042
- Testing
- Self-Management Workshop, Information Only
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- US Department of Veterans Affairs
Hepatitis C Virus Infection
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL)…
- Trial name
- NCT03022981
- Testing
- SOF/VEL
- Where
- 27 sites in United States, Belgium and 2 more
- Volunteers
- 216 people
- Sponsor
- Gilead Sciences
Liver Fibrosis
Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection
Patients who have been treated for hepatitis C virus (HCV) infection who have failed to respond to anti-viral treatment are often concerned about their ongoing liver disease and are therefore looking for alternative treatments…
- Trial name
- NCT00180674
- Testing
- Warfarin
- Where
- United Kingdom
- Volunteers
- 14 people
- Sponsor
- Imperial College London
Hepatitis C
Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)
This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis) multicenter study to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine…
- Trial name
- NCT01667081
- Testing
- Grazoprevir
- Volunteers
- 2,438 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C.
- Trial name
- NCT00104052
- Testing
- peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908)
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
HCV Infection
Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying…
- Trial name
- NCT03379506
- Testing
- EBR/GZR FDC Tablet, Grazoprevir Oral Granules, Elbasvir Oral Granules
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Merck Sharp & Dohme LLC