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

UnknownPhase 4

Sponsor: King Abdullah International Medical Research Center

Conditions: Hepatitis B

Interventions: PEG-IFN & Nucleos(t)tide analogues, Nucleos(t)tide analogues

Countries: Saudi Arabia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (3)

Jeddah, Saudi Arabia
Jeddah, Saudi Arabia
Riyadh, Saudi Arabia