NCT01649245

Brief Summary

It is a multi-center study of the efficacy of a new Pegylated Hansenula-derived recombinant interferon α 2a (Reiferon Retard® 160 µg once weekly in combination with ribavirin in treatment of Egyptian patients with chronic hepatitis C for 48 weeks. hepatitis C virus (HCV) viral load will be assessed during therapy at weeks 12, 24 and end of treatment, as well as 24 weeks after therapy is completed.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

January 15, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

July 20, 2012

Last Update Submit

January 12, 2013

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis CEgyptian patientspegylated interferonRibavirinReiferon retard

Outcome Measures

Primary Outcomes (1)

  • Sustained Virologic Response (SVR)

    Sustained Virologic Response (SVR) is assessed by measurement of HCV RNA viral load 24 weeks after the end of Therapy. SVR is defined as undetectable HCV RNA 24 weeks after the end of therapy.

    Assessed 24 weeks after the end of treatment

Secondary Outcomes (3)

  • Complete Early Virologic Response (cEVR)

    At week 12 of therapy

  • End of Treatment Response (ETR)

    at the end of therapy (48 weeks from initiation of therapy

  • Safety

    Throughout the duration of therapy (48weeks)

Study Arms (1)

Reiferon retard plus ribavirin

EXPERIMENTAL

Eligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is \>75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses

Drug: Reiferon retard

Interventions

Reiferon retardDRUG

Eligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is \>75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses.

Also known as: Pegylated interferon α 2a
Reiferon retard plus ribavirin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18 and \< 60.
  • BMI ≤ 30
  • Liver biopsy showing chronic hepatitis with significant fibrosis (F2 and F3 using Metavir scoring system) regardless of aminotransferase elevations.
  • F1 stage (by Metavir scoring system) with elevated aminotransferases.
  • Compensated liver disease; serum bilirubin \< 1.5 mg/dl, INR no more than 1.5, serum albumin ≥ 3.5 g/dl, platelet count ≥ 1000 cmm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
  • Acceptable hematological and biochemical indices (hemoglobin ≥ 11g/dl; total leukocytic count ≥ 3000/cmm, absolute neutrophil count ≥ 1500/cmm and serum creatinine \< 1.97 mg/dl.
  • Willing to be treated and to adhere to treatment requirements.

You may not qualify if:

  • Major uncontrolled depressive illness.
  • Solid organ transplantation.
  • Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
  • Untreated thyroid disease.
  • Pregnant or unwilling to comply with adequate contraception.
  • Severe concurrent medical disease, such as severe hypertension, heart failure, significant coronary artery disease, poorly controlled diabetes (HbA1C \> 8.5 %), and chronic obstructive pulmonary disease.
  • Known hypersensitivity to drugs used to treat HCV.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Liver Institute

Shebin El-Kom, Monufia Governorate, 22213, Egypt

RECRUITING

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Imam Waked, MD

    National Liver Institute, Egypt

    PRINCIPAL INVESTIGATOR

  • Gamal Esmat, MD

    Faculty of Medicine - Cairo University - Egypt

    PRINCIPAL INVESTIGATOR

  • Hassan Hamdy, MD

    Faculty of Medicine - Ain Shams University - Egypt

    PRINCIPAL INVESTIGATOR

  • Mohamed kohla, MD

    National Liver Institute, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

July 25, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 15, 2013

Record last verified: 2013-01

Locations

EG(1)