Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial... | NCT02762383

Studies
Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)

NCT02762383

Sponsor

Hoffmann-La Roche

Status

Terminated

Last Update Posted

Sep 7, 2016Estimated

Enrollment

19Actual

Phase

Phase 3

Conditions

HIV/HCV Coinfection

Interventions

Peginterferon Alfa-2

Countries

Belgium

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2004-002736-26	EudraCT Number

Status Module

Record Verification Date

May 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

May 3, 2016

First Submission Date that Met QC Criteria

May 3, 2016

First Posted Date

May 4, 2016Estimated

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

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Description Module

Brief Summary

This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). Participants with HIV/HCV who do not show negative or reduced HCV ribonucleic acid (RNA) after at least 12 weeks of treatment with peginterferon alfa-2a plus ribavirin will receive a low dose of peginterferon alfa-2a for 18 months. The primary objective is to evaluate safety and tolerability. Secondary objectives are to evaluate histological, virological, and biochemical effects.

Detailed Description

Not provided

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

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Peginterferon Alfa-2a	Experimental	Participants will receive a low dose of peginterferon alfa-2a for 18 months.	Drug: Peginterferon Alfa-2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peginterferon Alfa-2	Drug	Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.	Peginterferon Alfa-2a

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Adverse Events (AEs)		From Baseline to end of treatment (up to 18 months)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Histological Response According to Paired Biopsy		At end of treatment (up to 18 months)
HIV RNA Viral Load in Copies per Milliliter (copies/mL)		At end of treatment (up to 18 months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Serologic evidence of chronic hepatitis C infection by anti-HCV antibody test
Received peginterferon alfa-2a for at least 12 weeks and either did not reach a 2-log drop in HCV RNA after 12 weeks of treatment, did not reach an undetectable HCV RNA after 24 weeks of treatment, or reached undetectable HCV RNA that was detectable again at the end of 48 weeks of treatment
Detectable serum HCV RNA at Screening
Serologic evidence of HIV infection by HIV RNA detection
CD4 cell count greater than or equal to (>/=) 100 cells/mcL during therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
Stable HIV status and, if on antiretroviral therapy, a stable regimen for at least 6 weeks prior to Baseline
Compensated liver disease
No evidence of hepatocellular carcinoma

Exclusion Criteria:

Pregnant or breastfeeding
Antineoplastic or immunomodulatory treatment within 6 months prior to first dose
Any investigational drug within 6 weeks prior to first dose
Positive for hepatitis A immunoglobulin M antibody
Severe neutropenia or thrombocytopenia at Screening while still on therapy with peginterferon alfa-2a plus ribavirin
Severe psychiatric or neurologic comorbidity
History of any significant medical conditions, such as immune disorders or disease of the major organ systems
Uncontrolled thyroid disease
Severe retinopathy
Evidence of drug abuse

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

Facility	Status	City	State	ZIP	Country	Contacts
		Brussels		1000	Belgium