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

NCT01310205 | Completed

• 1 other identifier: SCI-SCV-HCV-P2-001-Extension
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Hepatitis C

Keywords

HCV; Genotype 1; relapsers; non cirrhotic; Chronic Hepatitis C

Study Arms (2)

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

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

Interventions

SCV-07 DRUG

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

Hepatitis C treatment; non cirrhotic subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• SciClone Pharmaceuticals: lead

Study Sites (4)

AGMG Clinical Research

Anaheim, California, 92803, United States

Location

Univ of Louisville Med/Dental Complex

Louisville, Kentucky, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Walter Reed Army Medical Center

Washington, Washington, 20307, United States

Location

Related Links

• Sponsor

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

golotimod

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katharina Modelska, MD

  SciClone Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 8, 2011
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 8, 2012

Record last verified: 2011-03

Locations

US (4)