48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
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| ClinicalTrials.gov Identifier: NCT00114361 |
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Recruitment Status :
Completed
First Posted : June 15, 2005
Last Update Posted : June 22, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis B | Drug: Ribavirin Drug: Peginterferon alpha 2a | Phase 3 |
Despite the introduction of newer drugs for the treatment of chronic hepatitis B, there is still no optimal treatment. Pegylated interferon alfa has proven sustained efficacy in approximately 30-40% of patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. It is likely that combination therapy of pegylated interferon alfa with ribavirin in chronic hepatitis B is more effective than pegylated interferon alfa monotherapy. In chronic hepatitis C, adding ribavirin to pegylated interferon therapy doubled the sustained response rate (29% vs. 56%) and has become the standard option of treatment.
To investigate the effect of the treatment with pegylated interferon and ribavirin on the amount of inflammation and fibrosis in the liver, a liver biopsy will be performed within one year prior to screening and at the end of follow-up.
When patients with chronic hepatitis B are treated outside any study with pegylated interferon, they visit the outpatient clinic approximately every month for blood samples. So in this study the amount of blood samples taken from every patient is not increased as compared with treatment outside a study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 138 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Double (Participant, Investigator) |
| Official Title: | Peginterferon Alfa-2a and Ribavirin Combination Therapy in Patients With HBeAg-negative Chronic HBV Infection (PARC Study) |
| Study Start Date : | March 2005 |
| Actual Primary Completion Date : | May 2008 |
| Actual Study Completion Date : | April 2010 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Ribavirin + Peg IFN
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Drug: Ribavirin
1200 mg a day, 48 weeks |
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Active Comparator: 2
Peg IFN + Placebo
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Drug: Peginterferon alpha 2a
180 µg per week, 48 weeks |
- The combined presence of HBV DNA level < 10E4 copies/ml and ALT normalization at the end of follow-up [ Time Frame: may 2008 ]
- ALT normalization [ Time Frame: May 2008 ]
- HBV DNA negativity(undetectable by Taqman PCR) [ Time Frame: May 2008 ]
- HBsAg loss from serum [ Time Frame: May 2008 ]
- Improvement liver histology [ Time Frame: May 2008 ]
- Combined virological, biochemical and histological response [ Time Frame: May 2008 ]
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic hepatitis B
- Biopsy performed within one year prior to screening or during screening
- ALT > 1.5 x ULN
- HBeAg negative, anti-HBeAg positive
- HBV DNA > 10E5 copies/ml
- Age 18-70 years
- Written informed consent
- Hepatic imaging without evidence of HCC
- All fertile males and females must be using two forms of effective contraception
Exclusion Criteria:
- Antiviral therapy against HBV within the previous 6 months; treatment with any investigational drug within 30 days of entry to this protocol
- Severe hepatitis activity as documented by ALT > 10 x ULN
- Advanced liver disease
- Pre-existent leucopenia or thrombopenia
- Co-infection with HCV,HDV or HIV
- Other acquired or inherited causes of liver disease
- Alpha fetoprotein > 50 ng/ml.
- Evidence of severe renal disease
- Hyper- or hypothyroidism
- Significant cardiovascular or pulmonary dysfunction, malignancy,immunodeficiency syndromes
- Immune suppressive treatment within the previous 6 months
- Contra-indications for alpha-interferon therapy
- Pregnancy, breast-feeding
- Any medical condition requiring chronic systemic administration of steroids
- Substance alcohol or drug abuse
- Subjects with clinically significant retinal abnormalities
- Subjects with clinically significant hearing abnormalities
- Hemoglobinopathies
- Subjects with known hypersensitivity to ribavirin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114361
| Netherlands | |
| Erasmus MC department hepatology | |
| Rotterdam, Netherlands, 3000CA | |
| Principal Investigator: | Harry LA Janssen, MD PhD | Foundation of Liver Research |
| Responsible Party: | Prof. H.L.A. Janssen, Foundation for Liver reseach |
| ClinicalTrials.gov Identifier: | NCT00114361 |
| Other Study ID Numbers: |
HBV05-01 EudraCT: 2004-004736-30 |
| First Posted: | June 15, 2005 Key Record Dates |
| Last Update Posted: | June 22, 2010 |
| Last Verified: | June 2010 |
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HBeAg-negative chronic hepatitis B viral |
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Hepatitis A Hepatitis B Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Ribavirin Peginterferon alfa-2a Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |