To Study the Effect of Adding on Pegylated Interferon (PEG-INF) Therapy for Patients Diagnosed With Chronic Hepatitis B

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess whether PEG-INF (Peglyated - interferon) Add-on therapy in patients of CHB who have achieved a maintained viral suppression (HBV DNA PCR( polymerase chain reaction) <200 for last 3-6 month) with NA's can result in increased rate of HBV infection eradication (HbsAg is undetectable by serological blood testing with or without seroconversion to HBs antibody).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Abdullah International Medical Research Center
• Collaborator: Hoffmann-La Roche
• Treatments: Interferons

Criteria

Inclusion Criteria:

• Adults ≥18 & < 70 years of both genders.

• CHB on NA's in maintained viral suppression (HBV DNA PCR <200 for last 3-6 month)

• Patients with measurable HBsAg quantitative levels

• Patients with any HBV genotypes.

• Patients with either CHB e Ag positive or eAg negative

• Patients who sign an informed consent for inclusion into the study.

• Patients with hepatitis Delta co-infection.

• only patients with a negative pregnancy test who are of child bearing potential and agree to utilize a strict birth control method will be enrolled

Exclusion Criteria:

• Patients with following characteristics will not be considered for the trial:

• Decompensated liver Cirrhosis

• HCV (hepatitis C virus) or HIV co infection.

• Autoimmune disorders like SLE (Systemic lupus erythematosus), RA (Rheumatoid Arthritis ), AIH (Autoimmune Hemolytic Anemia), ITP (Immune thrombocytopenic purpura), psoriasis etc.

• Untreated psychiatric conditions like depression and alcohol or drug abuse.

• Comorbid conditions like chronic renal failure or post renal/liver transplantation on immunosuppressive therapy.

• Complicated diabetes mellitus and advanced heart failure.

• Pregnancy or not willing to practice contraception.

• Known allergy to Interferons.

• Concomitant treatment with Telbivudine

• Evidence of portal hypertension by Biochemical (Low Platelets less than 100), imaging or UGI (upper gastrointestinal)endoscopy