An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B

NCT ID: NCT01787279

Last Updated: 2016-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2009-05-31

Brief Summary

This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peginterferon alpha-2a, 180 mcg/48 weeks

Eligible participants with HI3vAg (a type of Hepatitis B surface antigen) negative chronic hepatitis B will be administered peginterferon alpha-2a (PEGASYS), 40kD, 180 micrograms (mcg) subcutaneously once weekly for 48 weeks. The untreated Follow-up will be for 24 weeks.

Group Type: EXPERIMENTAL

Peginterferon alfa-2a [Pegasys]

Intervention Type: DRUG

180 mcg subcutaneously weekly, 48 weeks

Interventions

Peginterferon alfa-2a [Pegasys]

180 mcg subcutaneously weekly, 48 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adult patients, >/= 18 and </= 70 years of age
• HBeAg-negative chronic hepatitis B
• HBsAg-positive for at least 6 months, anti- hepatitis B (HBs) negative
• Serum alanine transaminase (ALT) > 2 ULN (upper limit of normal) but </= 10 x Upper limit of normal (ULN)
• Hepatitis B virus (HBV) DNA > 10'000 copies/ml (Roche Monitor or Taqman)
• No previous treatment with interferon (standard or pegylated) or with a nucleoside analogue
• Women of childbearing potential must agree to use reliable contraception during the study and for 3 months after treatment completion

Exclusion Criteria

• Previous antiviral interferon-based therapy for chronic hepatitis B
• Pregnant and lactating women
• Evidence of decompensated liver disease
• Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV)
• History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis
• Previous or current hepatocellular carcinoma
• History or other evidence of bleeding from oesophageal varices or other conditions consistent with decompensated liver disease
• Inadequate hematologic or renal function
• Serum bilirubin level > 2 times the upper limit of normal
• Severe psychiatric disease
• History of severe seizure disorder or current anticonvulsant use
• History of evidence of any disease or condition which would make the patient, in the opinion of the investigator, unsuitable for the study
• Evidence of drug abuse within one year of study entry
• Alcohol intake of more than 3 standard drinks per day for men and 2 standard drinks per day for women (1 standard drink contains 10 g of alcohol)
• Participation in another trial or receipt of an investigational drug within 12 weeks prior to screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Casablanca, , Morocco

Casablanca, , Morocco

Rabat, , Morocco

Rabat, , Morocco

Countries

Morocco

Other Identifiers

ML19522

Identifier Type: -

Identifier Source: org_study_id