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

Browse trials for

• Hepatitis A 2,709
• Hepatitis B 1,656
• Hepatitis B, Chronic 942
• Hepatitis 3,380

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 59 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  Peginterferon alpha-2a, 180 mcg/48 weeks

  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]

Interventions

• DrugPeginterferon alfa-2a [Pegasys]

  180 mcg subcutaneously weekly, 48 weeks

Primary outcomes

1. 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

2. 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

3. 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

Secondary outcomes

1. 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

2. 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

3. 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

Baseline characteristics