48 Weeks Combination Therapy for Patients With HBeAg-negative Chronic Hepatitis B Virus (HBV) Infection
Peginterferon Alfa-2a and Ribavirin Combination Therapy in Patients With HBeAg-negative Chronic HBV Infection (PARC Study)
2 other identifiers
interventional
138
1 country
1
Brief Summary
The purpose of this study is to investigate whether in patients with chronic HBeAg-negative hepatitis B, PEG-IFN-ribavirin combination therapy for 1 year leads to enhanced response (HBV DNA \<10E4 copies/ml and normal ALT 24 weeks after treatment discontinuation) in comparison with pegylated interferon (PEG-IFN) monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2005
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 14, 2005
CompletedFirst Posted
Study publicly available on registry
June 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 22, 2010
June 1, 2010
3.2 years
June 14, 2005
June 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The combined presence of HBV DNA level < 10E4 copies/ml and ALT normalization at the end of follow-up
may 2008
Secondary Outcomes (5)
ALT normalization
May 2008
HBV DNA negativity(undetectable by Taqman PCR)
May 2008
HBsAg loss from serum
May 2008
Improvement liver histology
May 2008
Combined virological, biochemical and histological response
May 2008
Study Arms (2)
1
ACTIVE COMPARATORRibavirin + Peg IFN
2
ACTIVE COMPARATORPeg IFN + Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erasmus MC department hepatology
Rotterdam, 3000CA, Netherlands
Related Publications (4)
Brakenhoff SM, de Knegt RJ, van Campenhout MJH, van der Eijk AA, Brouwer WP, van Bommel F, Boonstra A, Hansen BE, Berg T, Janssen HLA, de Man RA, Sonneveld MJ. End-of-treatment HBsAg, HBcrAg and HBV RNA predict the risk of off-treatment ALT flares in chronic hepatitis B patients. J Microbiol Immunol Infect. 2023 Feb;56(1):31-39. doi: 10.1016/j.jmii.2022.06.002. Epub 2022 Jul 2.
PMID: 35941076DERIVEDBrakenhoff SM, de Knegt RJ, Oliveira J, van der Eijk AA, van Vuuren AJ, Hansen BE, Janssen HLA, de Man RA, Boonstra A, Sonneveld MJ. Levels of Antibodies to Hepatitis B Core Antigen Are Associated With Liver Inflammation and Response to Peginterferon in Patients With Chronic Hepatitis B. J Infect Dis. 2022 Dec 28;227(1):113-122. doi: 10.1093/infdis/jiac210.
PMID: 35599306DERIVEDBrakenhoff SM, de Man RA, Boonstra A, van Campenhout MJH, de Knegt RJ, van Bommel F, van der Eijk AA, Berg T, Hansen BE, Janssen HLA, Sonneveld MJ. Hepatitis B virus RNA decline without concomitant viral antigen decrease is associated with a low probability of sustained response and hepatitis B surface antigen loss. Aliment Pharmacol Ther. 2021 Jan;53(2):314-320. doi: 10.1111/apt.16172. Epub 2020 Nov 21.
PMID: 33222190DERIVEDFarag MS, van Campenhout MJH, Pfefferkorn M, Fischer J, Deichsel D, Boonstra A, van Vuuren AJ, Ferenci P, Feld JJ, Berg T, Hansen BE, van Bommel F, Janssen HLA. Hepatitis B Virus RNA as Early Predictor for Response to Pegylated Interferon Alpha in HBeAg-Negative Chronic Hepatitis B. Clin Infect Dis. 2021 Jan 27;72(2):202-211. doi: 10.1093/cid/ciaa013.
PMID: 31912157DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harry LA Janssen, MD PhD
Foundation of Liver Research
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 14, 2005
First Posted
June 15, 2005
Study Start
March 1, 2005
Primary Completion
May 1, 2008
Study Completion
April 1, 2010
Last Updated
June 22, 2010
Record last verified: 2010-06