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Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
SCV-07
Sponsored by
SciClone Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Chronic Hepatitis C focused on measuring HCV, Genotype 1, relapsers, non cirrhotic, Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who satisfy all of the following criteria may be enrolled into the study:

Subjects must be able to understand and sign an ICF approved by the investigator's institutional review board (IRB) for this study; must have completed treatment on study SCI-SCV-HCV-P2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current SOC (peg-IFN and RBV).

Exclusion Criteria:

  • Subjects who satisfy any of the following criteria will not be enrolled into the study:

Subjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-IFN and RBV for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial.

Sites / Locations

  • AGMG Clinical Research
  • Univ of Louisville Med/Dental Complex
  • University of Cincinnati Medical Center
  • Walter Reed Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Arm Label

Hepatitis C treatment

non cirrhotic subjects

Arm Description

This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV

This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 4, 2011
Last Updated
March 7, 2012
Sponsor
SciClone Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01310205
Brief Title
Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV
Official Title
An Extension of Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Pegylated Interferon and Ribavirin After Completing Treatment in a Phase 2 Study and Have Relapsed After at Least 44 Weeks Tx With Peg-IFN and RBV.
Study Type
Observational

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciClone Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an extension of ongoing study SCI-SCV-HCV-P2-001 in which subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV.
Detailed Description
In this extension study, subjects will be asked to give permission to share their HCV RNA viral load test results, obtained from local laboratories, at the different time points and will also be asked to give permission to share their SOC dosing information (peg-IFN and RBV). As no SCV-07 treatment, procedures, or assessments will be required during this extension study, no related safety information will be collected. The study will last up to 72 weeks after subjects complete treatment on study SCI-SCV-HCV-P2-001 and begin retreatment with peg-IFN and RBV.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
HCV, Genotype 1, relapsers, non cirrhotic, Chronic Hepatitis C

7. Study Design

Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hepatitis C treatment
Arm Description
This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
Arm Title
non cirrhotic subjects
Arm Description
This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
Intervention Type
Drug
Intervention Name(s)
SCV-07
Intervention Description
This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who satisfy all of the following criteria may be enrolled into the study: Subjects must be able to understand and sign an ICF approved by the investigator's institutional review board (IRB) for this study; must have completed treatment on study SCI-SCV-HCV-P2-001; and must, in the judgment of the investigators, be able to benefit from retreatment per current SOC (peg-IFN and RBV). Exclusion Criteria: Subjects who satisfy any of the following criteria will not be enrolled into the study: Subjects who, in the opinion of the investigators, will be unable to tolerate retreatment with peg-IFN and RBV for at least 48 weeks and are at high risk of early treatment discontinuation and plan to participate in another investigational trial prior to providing a final sample for this trial.
Study Population Description
This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharina Modelska, MD
Organizational Affiliation
SciClone Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
AGMG Clinical Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92803
Country
United States
Facility Name
Univ of Louisville Med/Dental Complex
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
Washington
ZIP/Postal Code
20307
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sciclone.com
Description
Sponsor

Learn more about this trial

Extension Study SCI-SCV-HCV-P2-001: Long-Term FU in Subj Who Opt for Retreatment With Peg-INF and RBV After Completing Treatment in HCV

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