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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/07/009027
• Date of registration: 12-07-2017
• Prospective Registration: Yes
• Primary sponsor: F HoffmannLa Roche Ltd
• Public title: Study of Pegylated interferon alfa-2a in combination with Lamivudine or Entecavir in children with Chronic Hepatitis B
• Scientific title: A phase IIIB, randomized, open-label study of pegylated interferon alfa-2a in combination with Lamivudine or Entecavir compared with untreated control patients in children with HBeAg-positive Chronic Hepatitis B in the immune-tolerant phase
• Date of first enrolment: 29-09-2017
• Target sample size: 114
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12297
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Double Blind Double Dummy
• Phase: Phase 3

Countries of recruitment

Dominican Republic, Egypt, Germany, Guatemala, India, Romania, Russian Federation, Taiwan, Turkey, Ukraine, United Kingdom, United States of America

Contacts

• Name: Dr Aditi Parekh
• Affiliation: Roche Products India Pvt. Ltd.

• Name: Dr Binay Swarup
• Affiliation: Roche Products India Pvt. Ltd.

Key inclusion & exclusion criteria

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)

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Intervention1: PEGYLATED INTERFERON ALFA-2A IN COMBINATION WITH Lamivudine or Entecavir: Treated patients will receive lamivudine as a film-coated tablet or oral solution once daily at a dose of 3 mg/kg (maximum daily dose 100 mg) or entecavir as a film-coated tablet or oral solution at a dose of 0.015 mg/kg once daily (maximum dose of 0.5 mg), given alone for 8 weeks then in combination with Pegasys® for 48 weeks.Pegasys® will be
given subcutaneously once weekly with dosing based on BSA categories.
Control Intervention1: NIL: No treatment in second arm

Primary Outcome(s)

The primary efficacy outcome measure for this study is Safety at 24 weeks post treatment/end of untreated observationTimepoint: The primary efficacy outcome measure for this study is Safety at 24 weeks post treatment/end of untreated observation

Secondary Outcome(s)

Safey & EfficacyTimepoint: The secondary efficacy outcome measures for this study at 1, 2, 3, 4, and 5 years post end of

treatment

Secondary ID(s)

NV25361 Version 12 dated 15-Feb-2016

Source(s) of Monetary Support

F. Hoffman-La Roche Ltd, CH-4070 Basel, Switzerland

Ethics review

Status: Approved
Approval date: 02/03/2017
Contact:

KEM Hospital Research Centre Ethics Committee

Status: Approved
Approval date: 24/05/2017
Contact:

Institutional Ethics Committee, Sparsh Hospital

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee (IEC) Seth G.S Medical College and Kem Hospital

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee St. Johns Medical College & Hospital

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Institute of Child Health