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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SciClone Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01310205
First received: March 4, 2011
Last updated: March 7, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention
Chronic Hepatitis C
Drug: SCV-07

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by SciClone Pharmaceuticals:

Enrollment: 12
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hepatitis C treatment
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
Drug: SCV-07
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
non cirrhotic subjects
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
Drug: SCV-07
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310205

Locations
United States, California
AGMG Clinical Research
Anaheim, California, United States, 92803
United States, Kentucky
Univ of Louisville Med/Dental Complex
Louisville, Kentucky, United States
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Washington
Walter Reed Army Medical Center
Washington, Washington, United States, 20307
Sponsors and Collaborators
SciClone Pharmaceuticals
Investigators
Study Director: Katharina Modelska, MD SciClone Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: SciClone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01310205     History of Changes
Other Study ID Numbers: SCI-SCV-HCV-P2-001-Extension
Study First Received: March 4, 2011
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by SciClone Pharmaceuticals:
HCV
Genotype 1
relapsers
non cirrhotic
Chronic Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on July 24, 2014