Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects

NCT00964665 | Terminated Phase 1

• 2 other identifiers: CABF656A2206EudraCT 2008-006933-29
• Study Type: interventional
• Target: 141
• Locations: 5 countries
• Sites: 12

Brief Summary

This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B,; Chronic,; Hepatitis B e Antigens positive

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.

  48 weeks

Secondary Outcomes (1)

• Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b

  up to 12 weeks

Study Arms (5)

Group 1 ABF656 900ug Q2w

EXPERIMENTAL

Drug: albinterferon alfa-2b

Group 2 ABF656 900ug Q4w

EXPERIMENTAL

Drug: albinterferon alfa-2b

Group 3 AB656 1200ug Q4w

EXPERIMENTAL

Drug: albinterferon alfa-2b

Group 4 ABF656 1500ug Q4w

EXPERIMENTAL

Drug: albinterferon alfa-2b

Group 5 Pegasys® 180µg qw

ACTIVE COMPARATOR

Drug: Pegasys®

Interventions

albinterferon alfa-2b DRUG

Group 1 ABF656 900ug Q2w

Pegasys® DRUG

Group 5 Pegasys® 180µg qw

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
• Chronic HBV infection (serum HBsAg detectable for \> 6 months)
• Serum HBeAg positive with HBV DNA \>106copies/mL (or \>200,000 IU/mL)
• Serum ALT must be \> 2 x ULN but below 10 x ULN

You may not qualify if:

• Steroid treatment or immunosuppression 3 months prior to entry.
• Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
• Hb\< 10g/dL or, and ANC \< 750/mm3 or , and platelet count \< 75,000 mm3 .
• Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
• Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
• Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
• History of hypothyroidism or current treatment for thyroid disease.
• Patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Human Genome Sciences Inc.: collaborator

Study Sites (12)

Novartis Investigator Site

Beijing, China

Location

Novartis Investigator Site

Shatin, Hong Kong

Location

Novartis Investigator Site

Taipo, Hong Kong

Location

Novartis Investigator Site

Bialystok, Poland

Location

Novartis Investigator Site

Lodz, Poland

Location

Novartis Investigator Site

Warsaw, Poland

Location

Novartis Investigator Site

Kaohsiung City, Taiwan

Location

Novartis Investigator Site

Taipei, Taiwan

Location

Novartis Investigator Site

Tau-Yuan County, Taiwan

Location

Novartis Investigator Site

Bangkok, Thailand

Location

Novartis Investigator Site

Chiang Mai, Thailand

Location

Novartis Investigator Site

Songkhla, Thailand

Location

Related Publications (2)

• Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, Chutaputti A, Chang WY, Zahm FE, Pluck N. Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003 Jul;10(4):298-305. doi: 10.1046/j.1365-2893.2003.00450.x.

  PMID: 12823597 BACKGROUND

• Colvin RA, Tanwandee T, Piratvisuth T, Thongsawat S, Hui AJ, Zhang H, Ren H, Chen PJ, Chuang WL, Sobhonslidsuk A, Li R, Qi Y, Praestgaard J, Han Y, Xu J, Stein DS; ABF656A2206 Study Group. Randomized, controlled pharmacokinetic and pharmacodynamic evaluation of albinterferon in patients with chronic hepatitis B infection. J Gastroenterol Hepatol. 2015 Jan;30(1):184-91. doi: 10.1111/jgh.12671.

  PMID: 24995515 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Bronchiolitis Obliterans Syndrome

Interventions

albinterferon alfa-2b; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

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; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Institute for BioMedical Research

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Last Updated: January 6, 2011

Record last verified: 2011-01

Locations

CN (1); TW (3); PL (3); HK (2); TH (3)