Clinical trials: Chronic Hepatitis B Virus Infection
Chronic Hepatitis B, Pregnancy Complications
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored.
- Conditions
- Chronic Hepatitis B, Pregnancy Complications, High Viral Load, Elevated Alanine Aminotransferase Levels
- Trial name
- NCT01337791
- Testing
- Telbivudine treatment
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Southeast University, China
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
Combination Therapy With Interferon Plus Interleukin 2 and Hepatitis B Vaccine in Chronic Hepatitis B Patients
This study is a multi-center, randomized, prospective, open-label Phase IV Clinical trial to evaluate efficacy and safety of interferon alfa-2b therapy combinated with interleukin 2 and hepatitis B therapeutic vaccine versus…
- Trial name
- NCT02360592
- Testing
- Entecavir, Interferon alfa-2b, Interleukin 2
- Where
- 12 sites in China
- Volunteers
- 94 people
- Sponsor
- Tongji Hospital
Hepatitis B, Chronic
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
The purpose of this study is to determine if DV-601, an investigational, therapeutic vaccine will be well-tolerated and induce hepatitis B virus (HBV)-specific virological and immunological responses in chronic hepatitis B (CHB)…
- Trial name
- NCT01023230
- Testing
- DV-601, Entecavir
- Where
- 4 sites in Poland
- Volunteers
- 14 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Hepatitis B
Safety and Tolerability of TG1050: A Dose-finding Study
Methodology: This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection.
- Trial name
- NCT02428400
- Testing
- TG1050
- Where
- 12 sites in Canada, France and 1 more
- Volunteers
- 48 people
- Sponsor
- Transgene
Chronic Hepatitis B
TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for 12 Months
Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%.
- Trial name
- NCT04650828
- Testing
- TDF, Tenofovir Disoproxil Fumarate 300 MG
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Chronic Hepatitis B
Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy
Patients with Chronic Hepatitis B on long term oral antiviral therapy have to continue treatment indefinitely unless they achieve HBeAg seroconversion or HBsAg seroclearance, when therapy can be stopped.
- Trial name
- SWAP (NCT01928511)
- Testing
- peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly, Nucleos(t)ide analogue therapy
- Where
- 4 sites in Singapore
- Volunteers
- 254 people
- Sponsor
- Seng Gee Lim
Chronic Hepatitis B
A Phase II Dose Response Study in Japan in Chronic Hepatitis B
To demonstrate the dose response of entecavir in Japanese patients as measured by HBV DNA levels by PCR (log10 copies/mL) at Week 22
- Trial name
- NCT01022801
- Testing
- Entecavir
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
Objectives: Primary Objective: To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b…
- Trial name
- NCT02355951
- Testing
- blood draw
- Where
- 11 sites in Canada, France and 1 more
- Volunteers
- 166 people
- Sponsor
- Transgene
Chronic Hepatitis b
Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients
The aim of the prospective study is to determine whether combination/ sequential therapy with Entecavir, Peginterferon alfa-2b and immunomodulators Granulocyte Macrophage Colony Stimulating Factor (GMCSF)+vaccine could induce…
- Trial name
- NPGV (NCT03332329)
- Testing
- Entecavir, Granulocyte Macrophage Colony Stimulating Factor, Y peginterferon alfa-2b
- Volunteers
- 15 people
- Sponsor
- Qin Ning
Hepatitis B
Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection
The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents.
- Trial name
- NCT02479880
- Testing
- Tenofovir DF, DEXA Scan
- Where
- 11 sites in Belgium, France and 5 more
- Volunteers
- 30 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic, Pregnancy Related
Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B
Immunoprophylaxis failure of hepatitis B (HBV) remains a concern and has been reported in approximately 10-30% of infants born to highly viremic mothers with HBeAg-positive.
- Trial name
- NCT04211805
- Testing
- Tenofovir Alafenamide 25 MG for arm (A), Tenofovir Disoproxil Fumarate 300mg for arm (B)
- Where
- 11 sites in China
- Volunteers
- 450 people
- Sponsor
- New Discovery LLC
Hepatitis B
A Phase II Study to Determine the Safety and Efficacy of Interferon-gamma in Patients With Chronic Hepatitis B
Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in…
- Trial name
- NCT00753467
- Testing
- IFN-γ 1b (Actimmune), Adefovir dipivoxil, IFN-γ 1b and Adefovir dipivoxil combination
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Huntington Medical Research Institutes
Hepatitis B
Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B
This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.
- Trial name
- NCT00128544
- Testing
- telbivudine, valtorcitabine
- Where
- 3 sites in Hong Kong, New Zealand and 1 more
- Volunteers
- 130 people
- Sponsor
- Novartis
Hepatitis B, Chronic
A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection
The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.
- Trial name
- OSPREY (NCT05123599)
- Testing
- JNJ-73763989, JNJ-64300535, ETV monohydrate
- Where
- 13 sites in Belgium, France and 6 more
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic, Pregnancy
Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients
This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.
- Trial name
- NCT02327702
- Testing
- Emtricitabine
- Volunteers
- 200 people
- Sponsor
- Asian-Pacific Alliance of Liver Disease, Beijing
Hepatitis c
Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection
Two Groups of Genotype 4 HCV Patients will participate through open-label randomized Study comparing Sofosbuvir tablet Plus Ribavirin tablet (Part A) versus single Dose (2 tablets) of EHCV containing Sofosbuvir, Ribavirin, and…
- Trial name
- NCT02483156
- Testing
- Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg, Sofosbuvir tablet (SOF) 400 mg - once daily, Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Egyptian Liver Hospital
Chronic Hepatitis B, Chronic Hepatitis C
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.
- Trial name
- FIBROELAST (NCT01360879)
- Where
- Japan
- Volunteers
- 500 people
- Sponsor
- Kindai University
Chronic Hepatitis B
A Study to Evaluate the Mass Balance Absorption and AME of VBR
This Phase 1 Study will determine the mass balance recovery, absorption, metabolism, and excretion of [14C] Vebicorvir in healthy male subjects
- Trial name
- NCT04637139
- Testing
- Vebicorvir (VBR)
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Assembly Biosciences