Clinical trials: Chronic Hepatitis
Hepatitis B, Chronic
Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B
The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.
- Trial name
- NCT00410072
- Testing
- Entecavir, Entecavir + Tenofovir
- Where
- 68 sites in United States, Argentina and 11 more
- Volunteers
- 669 people
- Sponsor
- Bristol-Myers Squibb
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
Chronic Hepatitis B
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
- Trial name
- NCT00316719
- Testing
- LAM group, ADV group
- Volunteers
- 105 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic Disease
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
- Trial name
- NCT00096785
- Testing
- entecavir, adefovir
- Where
- 24 sites in United States, Canada and 6 more
- Volunteers
- 69 people
- Sponsor
- Bristol-Myers Squibb
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
Chronic Hepatitis B
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
- Trial name
- NCT00142298
- Testing
- Telbivudine (LdT)
- Where
- 39 sites in United States, Australia and 19 more
- Volunteers
- 1,869 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B Virus, HBV
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.
- Trial name
- NCT01438424
- Testing
- Entecavir, Lamivudine
- Volunteers
- 1,053 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
Suboptimal Responders to Adefovir Switching to Entecavir
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
- Trial name
- NCT00718887
- Testing
- Entecavir, Adefovir/Entecavir
- Where
- 8 sites in China
- Volunteers
- 228 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
- Trial name
- DEFINE (NCT00410202)
- Testing
- Entecavir, Tenofovir, Adefovir
- Where
- 67 sites in United States, Australia and 16 more
- Volunteers
- 629 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.
- Trial name
- NCT01368497
- Testing
- Entecavir and peginterferon
- Where
- 7 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis B, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01519960
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 39 sites in United States, Australia and 10 more
- Volunteers
- 165 people
- Sponsor
- Hoffmann-La Roche
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 B, Chronic
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
- Trial name
- NCT00423891
- Testing
- Entecavir
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 64 people
- Sponsor
- Bristol-Myers Squibb
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
Chronic Hepatitis B
Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection
The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d.
- Trial name
- NCT02058108
- Testing
- Telbivudine
- Where
- 29 sites in Bulgaria, Greece and 5 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B, Chronic
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
- Trial name
- NCT00395018
- Testing
- entecavir
- Where
- 32 sites in United States, Argentina and 7 more
- Volunteers
- 109 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic…
- Trial name
- NCT01651403
- Testing
- Tenofovir DF
- Where
- 21 sites in United States, India and 3 more
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences