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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
180 mcg subcutaneously weekly, 48 weeks
Unnamed facility
Casablanca, Morocco
Unnamed facility
Casablanca, Morocco
Unnamed facility
Rabat, Morocco
Unnamed facility
Rabat, Morocco
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.
Time frame: 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.
Time frame: 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
Time frame: Up to Week 72
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.
Time frame: At Week 72
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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.
Time frame: 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.
Time frame: At Week 72