An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chron… (NCT01787279) | Clinical Trial Compass
CompletedPhase 4
An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B
Morocco59 participantsStarted 2006-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 stu…
What they're measuring
1
Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72
Timeframe: At Week 72
2
Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72
Timeframe: At Week 72
3
Number of Participants With Any Adverse Events and Serious Adverse Events