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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Peginterferon alfa-2a [Pegasys]


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peginterferon alpha-2a, 180 mcg/48 weeks<br>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. | Drug: Peginterferon alfa-2a [Pegasys]<br>* 180 mcg subcutaneously weekly, 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72 | Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported. | At Week 72 | 
| Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72 | Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported. | At Week 72 | 
| Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above | Up to Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72 | Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported. | At Week 72 | 
| Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48 | Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive. | At Screening and Week 48 | 
| Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72 | Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported. | At Week 72 |