NCT02168361

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 4, 2016

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

June 17, 2014

Results QC Date

February 5, 2016

Last Update Submit

March 11, 2016

Conditions

Chronic Hepatitis C

Keywords

cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Serum HCV RNA Level

    4 and 12 weeks into therapy

Study Arms (2)

Standard

ACTIVE COMPARATOR

Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks

Drug: Pegylated Interferon alfa-2bDrug: RibavirinDrug: Sofosbuvir

Simeprevir + Sofosbuvir

EXPERIMENTAL

(SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks

Drug: SimeprevirDrug: Sofosbuvir

Interventions

Pegylated Interferon alfa-2bDRUG

1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total

Also known as: Pegintron
Standard
SimeprevirDRUG

150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks

Also known as: Olysio
Simeprevir + Sofosbuvir
RibavirinDRUG

1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir

Also known as: Ribavirin Ribasphere Ribapak
Standard
SofosbuvirDRUG

12 weeks of combination sofosbuvir and simeprevir

Also known as: Sovaldi
Simeprevir + SofosbuvirStandard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Hepatitis C

Atlanta, Georgia, 30309, United States

Location

Related 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):762-70.e2; quiz e11-2. doi: 10.1053/j.gastro.2014.12.027. Epub 2014 Dec 31.

    PMID: 25557952RESULT

MeSH Terms

Conditions

Hepatitis C, ChronicFibrosis

Interventions

peginterferon alfa-2bSimeprevirRibavirinSofosbuvir

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsRibonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesUridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingNucleotidesRibonucleotides

Results Point of Contact

Title
Dr. Brian Pearlman
Organization
Center for Hepatitis C
brianpearlman3@hotmail.com
4042651044

Study Officials

  • Brian L Pearlman, MD

    Center for Hepatitis C

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 20, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

March 14, 2016

Results First Posted

March 4, 2016

Record last verified: 2016-03

Locations

US(1)