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

NCT02982837 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2018-03-09

No results posted yet for this study

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).

Conditions

Interventions

DRUG

PEG-IFN & Nucleos(t)tide analogues

Subjects who will be randomized to receive 180 Mcg/ week as an add-on Pegylated Interferon therapy α-2 A with their ongoing NUCLEOTIDE analogues for 48 weeks.

DRUG

Nucleos(t)tide analogues

Subjects will continue on the same dose of Nucleoside/nucleotide analogues as they started the study.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • King Abdullah International Medical Research Center

    lead OTHER

Principal Investigators

  • Abduljaleel Alalwan, MD · National Guards Health Affairs-Riyadh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-03-31
Completion
2019-05-31

Countries

  • Saudi Arabia

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02982837 on ClinicalTrials.gov