The SIM-SOF Trial for Hepatitis C

Chronic Hepatitis C Clinical Trial

Official title:

The SIM-SOF Trial: A Randomized Trial Comparing Simeprevir-Sofosbuvir Versus Peginterferon/Ribavirin/Sofosbuvir for the Treatment of Chronic Hepatitis C Genotype-1a-infected Patients With Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168361
• Other study ID #: CHC-21
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2014
• Last updated: March 11, 2016
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Center For Hepatitis C, Atlanta, GA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Description:

Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• chronic hepatitis c,

• cirrhosis biopsy-proven, or via fibrotest,

• CPT score less than 7,

• genotype 1a,

• INR 2.3 or less,

• serum albumin greater than 2.7 gm/dL,

• total bilirubin less than 3 gm/dL,

• platelet count 50,000 per cubic milliliter or more

• GFR >50 ml/min

Exclusion Criteria:

• non genotype 1a,

• history of CPT class B or C or decompensation or history of same,

• HIV or HBV coinfection,

• prior treatment with boceprevir, telaprevir or any other direct acting antiviral agent,

• uncontrolled psychiatric or cardiopulmonary disorders,

• planning pregnancy or unwilling/unable to practice contraception

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegylated Interferon alfa-2b
1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
• Simeprevir
150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
• Ribavirin
1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
• Sofosbuvir
12 weeks of combination sofosbuvir and simeprevir

Locations

Country	Name	City	State
United States	Center for Hepatitis C	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Center For Hepatitis C, Atlanta, GA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pearlman BL, Ehleben C, Perrys M. The combination of simeprevir and sofosbuvir is more effective than that of peginterferon, ribavirin, and sofosbuvir for patients with hepatitis C-related Child's class A cirrhosis. Gastroenterology. 2015 Apr;148(4):762-7 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Sustained Virologic Response 12 (SVR-12)	Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy	12 weeks post-therapy	No
Secondary	Serum HCV RNA Level		4 and 12 weeks into therapy	No