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

Hepatitis B, Chronic Clinical Trial

Official title:

Expanded Access Programme of PEGASYS® (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-negative Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787279
• Other study ID #: ML19522
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2013
• Last updated: November 2, 2015
• Start date: January 2006
• Est. completion date: April 2012

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Morocco: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 and </= 70 years of age

• HBeAg-negative chronic hepatitis B

• HBsAg-positive for at least 6 months, anti-HBs negative

• Serum alanine transaminase (ALT) > 2 ULN (upper limit of normal) but </= 10 x ULN

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• peginterferon alfa-2a [Pegasys]
180 mcg subcutaneously weekly, 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving HCV DNA <10'000 copies/ml (Roche PCR or Taqman tests)		approximately 6 years	No
Primary	Percentage of patients achieving normalization of alanine aminotransferase (ALT)		approximately 6 years	No
Primary	Safety: Incidence of adverse events		approximately 6 years	No
Secondary	Percentage of patients achieving HBV DNA < 400 copies/ml (Roche PCR or Taqman tests)		approximately 6 years	No
Secondary	Percentage of patients achieving HBsAg seroconversion (HBsAg-negative, anti-HBs positive)		approximately 6 years	No
Secondary	Percentage of patients achieving combined response (HBV DNA < 10'000 copies/ml and normal ALT)		approximately 6 years	No