Effectiveness and Side Effects of Pegylated Interferon Al... | NCT00527540

Studies
Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

NCT00527540

Sponsor

Tehran Hepatitis Center

Status

Completed

Last Update Posted

Jan 21, 2009Estimated

Enrollment

60Estimated

Phase

Phase 3

Conditions

Hepatitis C

Interventions

Pegylated Interferon alpha 2a + Ribavirin

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jun 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Sep 8, 2007

First Submission Date that Met QC Criteria

Sep 8, 2007

First Posted Date

Sep 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2009

Last Update Posted Date

Jan 21, 2009Estimated

Name	Class
Kermanshah University of Medical Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.

Detailed Description

We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Pegylated Interferon alpha 2a + Ribavirin	Drug	Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day		Pegaferon

Measure	Description	Time Frame
End of treatment response rate (HCV RNA:Neg)		End of treatment course

Measure	Description	Time Frame
Sustain response rate (HCV RNA:Neg) 6 month after end of treatment		6 month after end of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HCV RNA: Positive
Biopsy approved in genotype 1
Age older than 18 yrs

Exclusion Criteria:

ongoing pregnancy or breast feeding
Hx of hemochromatosis
Hx of metabolic liver dis.
Hx of HCC
Hx of autoimmune hepatitis
Hx of alcoholic liver dis.
Hx of bleeding from esophageal varices
ongoing systemic anti-viral or anti-neoplasmic treatment
Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time
Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time
Hx of hospitalization for psychiatric dis.
Hx of suicidal attempt
Hx of IBD
Hx of SLE
Hx of scleroderma
Hx of rheumatoid arthritis
Hx of ITP
Hx of autoimmune hemolytic anemia
Hx of severe psoriasis
Hx of chronic pulmonary dis. associated with functional limitation
Hx of MI or unstable angina
Hx of arrhythmia requiring ongoing treatment
Hx of functional class III or IV
Hx of severe seizure dis. or current anti-convulsant use
Hx of organ transplantation with existing functional graft
Hx of severe retinopathy
Hx of Thalassemia
Hx of spherocytosis
Hx of cerebrovascular dis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seyed M Alavian, Prof.	Tehran Hepatitis Center	Study Chair
Behzad Hajarizadeh, MD	Tehran Hepatitis Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tehran Hepatitis Center		Tehran	Tehran Province		Iran

Type	Date	Date Unknown
Release	Feb 23, 2009
Reset	Mar 18, 2009

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides