Peg-interferon for Inactive Chronic Hepatitis B Carriers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02992704
• Date of registration: 12/12/2016
• Prospective Registration: No
• Primary sponsor: Seng Gee Lim
• Public title: Peg-interferon for Inactive Chronic Hepatitis B Carriers INACTIVE
• Scientific title: Randomised Control Study for Inactive Chronic Hepatitis B Patients With Low Viral Load, With Peg-Interferon (INACTIVE)
• Date of first enrolment: August 2016
• Target sample size: 90
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02992704
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Singapore

Contacts

• Name: Seng Gee Lim, MBBS, FRACP, FRCP, MD
• Affiliation: National University Health System

Key inclusion & exclusion criteria

Inclusion Criteria:

- Treatment naïve

- Documented HBsAg or HBV DNA positive for = 6 months.

- Documented HBeAg negative and anti-HBe positive

- ALT =1xULN

- quantitative HBsAg <1,000 IU/ml

- HBV DNA <2x104 IU/mL at screening

- Absence of cirrhosis documented by liver biopsy or transient elastography within 6
months (Fibroscan®; Fibrosis stage >2 (score = 10Kpa) will not be eligible for this
study.)

- Patient has agreed not to take any other investigational drug or systemic anti-viral,
cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies
unless clinically indicated.

- Patient is able to give written consent prior to study start and to comply with the
study requirements.

- Women of childbearing age must have a negative urine (ß-HCG) pregnancy test taken
within 14 days of starting therapy

Exclusion Criteria:

- Patients who are currently on treatment with nucleoside/nucleotide analogues or have
been treated for Hepatitis B in the past

- Presence of cirrhosis documented by liver biopsy or transient elastography (score =
10kpa)

- Active Co-infection with HIV antibody, HCV antibody or HDV antibody positivity.

- Evidence of decompensated liver disease defined as a direct (conjugated) bilirubin
>1.2x upper limit of normal (ULN), prothrombin time (PT) >1.5xULN , serum bilirubin
<35g/L, or prior history of clinical hepatic decompensation as illustrated by presence
of (eg. ascites, encephalopathy, variceal haemorrhage)

- Evidence of hepatocellular carcinoma

- Absolute neutrophil count <1.5x10^9/L or Hemoglobin <12 g/L for men or <11 g/L for
women, or platelet count < 90x10^9/L

- History of depression or psychiatric disease

- Uncontrolled thyroid disease defined as thyroid-stimulating hormone (TSH) >1.2 ULN or
0.8xLLN or thyroid dysfunction

- Any immunomodulators, systemic cytotoxic agents, or systemic cortiosteriods within 6
months before trial entry

- Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone
disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta,
osteochrondroses, multiple bone fractures)

- Malignant disease within 5 years of trial entry

- Women who are pregnant and who are not practicing adequate birth control measures,
(defined as two methods of birth control with at least one barrier method) or who are
lactating.



Age minimum: 21 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Carrier of Viral Hepatitis Type B

Chronic Hepatitis, B Virus

Intervention(s)

Drug: Peginterferon Alfa-2A

Primary Outcome(s)

HBsAg loss [Time Frame: 24 weeks after end of therapy]

Secondary Outcome(s)

proportion of patients with undetectable HBV DNA [Time Frame: At week 24, 48 of therapy, and 24 weeks after end of therapy]

HBsAg loss [Time Frame: At the end of 24 and 48 weeks of peginterferon therapy]

Decline in quantitative HBsAg level [Time Frame: At week 24, 48 and 24 weeks after completion of therapy]

Secondary ID(s)

2014/00205

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG