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

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Roche

Status and phase

Completed
Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: Peginterferon alfa-2a [Pegasys]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01787279
ML19522

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 1 patient group

Peginterferon alpha-2a, 180 mcg/48 weeks
Experimental group
Description:
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.
Treatment:
Drug: Peginterferon alfa-2a [Pegasys]

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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