A Study of Early Immunologic Response in Asian Patients With Chronic Hepatitis B, Treated With Pegasys (Peginterferon Alfa-2a (40KD)), Nucleoside Analogues, or Both

NCT00962871 | Completed Phase 1 Results

• 1 other identifier: PP22512
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 6

Brief Summary

This open-label, randomized, parallel-arm study will assess the early immunologic response in treatment-naïve Asian male patients with chronic hepatitis B after initiation of treatment with Pegasys or tenofovir or Pegasys plus tenofovir. Patients will be randomized to one of 4 cohorts to receive either Pegasys (360mcg subcutaneously weekly) or tenofovir (300mg orally daily) or both or no treatment for 2 weeks. After 2 weeks on study treatment, patients may opt to receive standard of care treatment with Pegasys. Target sample size is \<50.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Viral Quantitative e Antibody

  An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.

  Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

Secondary Outcomes (2)

• Mean Change From Baseline in HBV-DNA log10

  Day 1, 3, 5, 8, 10, 14, Week 3, 4, 5, 6 (weeks are computed from the first dose of Pegasys)

• Early Changes in Viral Sequence Associated With Viral Suppression

  Day 1, 5, 14, Week 4 and 6

Study Arms (4)

1

ACTIVE COMPARATOR

Drug: tenofovir

2

EXPERIMENTAL

Drug: peginterferon alfa-2a [Pegasys]; Drug: tenofovir

3

EXPERIMENTAL

Drug: peginterferon alfa-2a [Pegasys]

4

NO INTERVENTION

Interventions

peginterferon alfa-2a [Pegasys] DRUG

360 micrograms sc/week for 2 weeks

2; 3

tenofovir DRUG

300mg po daily for 2 weeks

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male adults of Southeast and/or East Asian origin, 18-55 years of age
• HBeAg-positive chronic hepatitis B
• detectable HBV DNA

You may not qualify if:

• prior antiviral therapy for chronic hepatitis B
• evidence of bridging fibrosis, cirrhosis or decompensated liver disease
• positive test at screening for HAV (IgM), HCV, HDV or HIV
• history or evidence of medical condition associated with chronic liver disease
• antineoplastic or immunomodulatory treatment \</=6 months prior to first dose of study drug

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

San Francisco, California, 94143-0538, United States

Location

Unknown Facility

Grafton, 1010, New Zealand

Location

Unknown Facility

Singapore, 119228, Singapore

Location

Unknown Facility

Singapore, 169608, Singapore

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Related Publications (2)

• Mehrotra A, D'Angelo JA, Romney-Vanterpool A, Chu T, Bertoletti A, Janssen HLA, Gehring AJ. IFN-alpha Suppresses Myeloid Cytokine Production, Impairing IL-12 Production and the Ability to Support T-Cell Proliferation. J Infect Dis. 2020 Jun 16;222(1):148-157. doi: 10.1093/infdis/jiaa064.

  PMID: 32049318 DERIVED

• Hong LZ, Hong S, Wong HT, Aw PP, Cheng Y, Wilm A, de Sessions PF, Lim SG, Nagarajan N, Hibberd ML, Quake SR, Burkholder WF. BAsE-Seq: a method for obtaining long viral haplotypes from short sequence reads. Genome Biol. 2014;15(11):517. doi: 10.1186/PREACCEPT-6768001251451949.

  PMID: 25406369 DERIVED

Related Links

• This report describes the early effects of IFNα treatment on immune and viral biomarkers in HBeAg+ CHB patients. The results show that PegIFNα-induced innate immune activation directly benefits from the suppression of HBV replication.

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a; Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 8, 2016
• Results First Posted: January 13, 2016

Record last verified: 2016-01

Locations

US (2); NZ (1); SG (2); TW (1)