Clinical trials: Hepatitis B Infections
Viral Hepatitis B, Viral Hepatitis D
Replicor Compassionate Access Program
The goal of this compassionate access program is to provide early access to REP 2139-Mg for patients with HBV mono-infection or HBV / HDV co-infection who either have advanced (decompensated) cirrhosis or who have failed to…
- Conditions
- Viral Hepatitis B, Viral Hepatitis D, Cirrhosis, Liver, Decompensated Cirrhosis
- Trial name
- RCAP (NCT05683548)
- Testing
- REP 2139-Mg, Tenofovir Disoproxil Fumarate, Pegylated interferon alpha2a
- Where
- 13 sites in Austria, France and 3 more
- Sponsor
- Replicor Inc.
Chronic Hepatitis B
An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to its commercial availability to people with lamivudine-resistant chronic hepatitis B who have limited treatment options.
- Trial name
- NCT00042393
- Testing
- Adefovir Dipivoxil
- Sponsor
- Gilead Sciences
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
- Trial name
- NCT00034359
- Testing
- ACH-126,443, Lamivudine
- Where
- 3 sites in Bulgaria, Federal Republic of Yugoslavia
- Volunteers
- 79 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Hepatitis B
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection.
- Trial name
- NCT00388674
- Testing
- entecavir, Other anti-HBV medication
- Where
- 290 sites in United States, Argentina and 22 more
- Volunteers
- 12,522 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
A Confirmatory Study of Hepabulin IV in HBsAg Positive Liver Transplantation Recipients
The purpose of this study is to Evaluate the efficacy and safety of Hepabulin IV (HBIG, a study drug) after liver transplantation.
- Trial name
- NCT01513850
- Testing
- Hepabulin IV
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- SK Chemicals Co., Ltd.
Chronic Hepatitis B
Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients
This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB.
- Trial name
- NCT00441974
- Testing
- adefovir dipivoxil
- Where
- 25 sites in China
- Volunteers
- 1,470 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis, Hepatitis B
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.
- Trial name
- QUASH2 (NCT00496158)
- Testing
- Clevudine, Adefovir
- Where
- 119 sites in United States, Argentina and 9 more
- Sponsor
- Pharmasset
Chronic Hepatitis B
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of…
- Trial name
- NCT00095121
- Testing
- Adefovir Dipivoxil (ADV), Lamivudine
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past.
- Trial name
- NCT00487747
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 23 sites in Russia
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects
The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its…
- Trial name
- NCT04309526
- Testing
- NCO-48 Fumarate
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nucorion Pharmaceuticals, Inc.
Chronic Hepatitis B
Long-term Safety and Efficacy Study of LB80380 in the Treatment-naive Patients of Chronic Hepatitis B
The purpose of the study is to investigate the long-term safety and the antiviral activity of the optimal doses of LB80380 for additional 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to…
- Trial name
- LB80380 (NCT01242787)
- Testing
- LB80380, Entecavir 0.5 mg
- Where
- 2 sites in China, South Korea
- Volunteers
- 115 people
- Sponsor
- LG Life Sciences
Chronic HBV Infection (HBeAg Negative)
REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection
REP 2139-Ca is nucleic acid polymer. Nucleic acid polymers have been previously shown to clear serum hepatitis B virus surface antigen (HBsAg) both preclinically (in duck HBV infected ducks) and in human patients and to act…
- Trial name
- NCT02233075
- Testing
- REP 2139-Ca + Pegasys (TM)
- Where
- Moldova
- Volunteers
- 12 people
- Sponsor
- Replicor Inc.
Hepatitis B, Chronic
Evaluation of Serum Levels and Pharmacokinetics of a New Hepatitis B Immune Globulin Following Liver Transplantation
The purpose of this study is to determine whether protective anti-HB serum levels are maintained after 6 months of uninterrupted treatment with IGIV-HB Grifols, a new specific hepatitis B immune globulin, in patients having…
- Trial name
- NCT00838071
- Testing
- Specific intravenous anti-hepatitis B immunoglobulin
- Where
- 4 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Instituto Grifols, S.A.
Hepatitis B, Chronic, Hepatitis D, Chronic
A Long Term Follow-up Study of Patients From the REP 301 Protocol
The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN).
- Trial name
- NCT02876419
- Where
- Moldova
- Volunteers
- 11 people
- Sponsor
- Replicor Inc.
Hepatitis B, Chronic
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with chronic HBV Infection.
- Trial name
- NCT02065336
- Testing
- ARC-520, entecavir, chlorpheniramine
- Where
- 2 sites in Hong Kong
- Volunteers
- 58 people
- Sponsor
- Arrowhead Pharmaceuticals
Diphtheria, Tetanus
Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks
A multicenter, observational study to evaluate the safety of Euforvac-Hib vaccine for active primary immunization against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenza type B in infants.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02257645
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Hepatitis B, Chronic
To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)
This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks.
- Trial name
- NCT00537537
- Testing
- Telbivudine
- Where
- 3 sites in India
- Volunteers
- 100 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B, HBV
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules.
- Trial name
- NCT01590641
- Testing
- Single Ascending Dose (SAD) Cohorts GS-9620, Multiple Ascending Dose (MAD) Cohorts
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 49 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A Efficacy and Safety Study of Adefovir Dipivoxil to Treat Chinese Patients With HBeAg+ve Chronic Hepatitis B
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
- Trial name
- NCT00857675
- Testing
- AAAA, AAPA, PAAA
- Where
- 10 sites in China
- Volunteers
- 480 people
- Sponsor
- GlaxoSmithKline