Study of Pegylated interferon alfa-2a in combination with Lamivudine or Entecavir in children with Chronic Hepatitis B

Phase 3

• Conditions: Health Condition 1: null- CHILDREN WITH HBEAG-POSITIVE CHRONIC HEPATITIS B IN THE IMMUNE-TOLERANT PHASE

• Registration Number: CTRI/2017/07/009027
• Lead Sponsor: F HoffmannLa Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 114

Inclusion Criteria

1. Male or female patients 3â??17 years of age at baseline (or 12 â??17 years of age at baseline in

Russia)

2. Positive for HBsAg and HBeAg for more than 6 months prior to baseline

3. Detectable HBV-DNA ( > 10,000 copies/mL [ > 2000 IU/mL]) (as measured by polymerization chain reaction [PCR] or hybridization) on at least 2 occasions one month apart with at least one of the determinations obtained <= 42 days prior to baseline.

4. Compensated liver disease (Child-Pugh Class A clinical classification)

Exclusion Criteria

1. Patients who have received investigational drugs or licensed treatments with anti HBV

activity (e.g., interferons [IFNs], lamivudine, tenofovir, emtricitabine, adefovir, entecavir,

telbivudine, systemic acyclovir, systemic famciclovir) (Exception: Patients who have had a

limited [<= 7-day] course of acyclovir for herpetic lesions more than 1 month before the study baseline visit are not excluded.)

2. Patients who have participated in any other clinical trial or who have received any

investigational drug within 6 months prior to baseline

3. Known hypersensitivity to IFN, Pegasys or lamivudine

4. History of immunologically mediated disease to include, but not limited to: autoimmune

hepatitis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus

erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or clinical

evidence of rheumatoid arthritis

5. History of solid organ or bone marrow transplantation

6. History or other evidence of severe retinopathy

7. History or other evidence of severe illness or any other conditions that would make the

patient, in the opinion of the investigator, unsuitable for the study

8. Active substance abuse within 6 months prior to screening

9. Sexually active females of childbearing potential and sexually active males who are not

willing to utilize reliable contraception during treatment and for 90 days following the end of

treatment

10. Females who are pregnant or who are breastfeeding. (Females of childbearing potential

who have a positive urine or serum pregnancy test result within 24 hours of baseline are

excluded)

Study & Design

• Study Type: Interventional
• Study Design: Not specified