Clinical trial NCT01787279: An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B
Official title: Expanded Access Programme of PEGASYS® (Peg Interferon Alpha-2a 40KD) in Patients With HBe-Ag-negative Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72
timeFrame: At Week 72
measure: Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72
timeFrame: At Week 72
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to Week 72
Secondary outcomes:
measure: Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72
timeFrame: At Week 72
measure: Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48
timeFrame: At Screening and Week 48
measure: Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72
timeFrame: At Week 72
Other outcomes:
Locations:
city: Casablanca
country: Morocco
city: Casablanca
country: Morocco
city: Rabat
country: Morocco
city: Rabat
country: Morocco
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: