Phase 4
Completed N=59
An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B
Hepatitis B, Chronic
Source: ClinicalTrials.gov NCT01787279 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72 — 65.4 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72 |
65.4 | — |
| PRIMARY Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72 |
68.6 | — |
| PRIMARY Number of Participants With Any Adverse Events and Serious Adverse Events |
46; 0 | — |
| SECONDARY Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72 |
26.9 | — |
| SECONDARY Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 |
1.7; 10.9; 0; 10.9 | — |
| SECONDARY Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72 |
58.8 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 and 2 ULN (upper limit of normal) but 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
Data sourced from ClinicalTrials.gov (NCT01787279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.