The SIM-SOF Trial for Hepatitis C

Status Completed

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.

Clinical Trial 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 ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02168361
Study type	Interventional
Source	Center For Hepatitis C, Atlanta, GA
Contact
Status	Completed
Phase	Phase 4
Start date	December 2013
Completion date	April 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01937975` - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)	Phase 1
Completed	`NCT03673696` - The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects	Phase 1
Completed	`NCT02250001` - Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C	N/A
Completed	`NCT03088917` - 'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
Completed	`NCT02207088` - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease	Phase 3
Not yet recruiting	`NCT02865369` - Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment	N/A
Recruiting	`NCT02638233` - Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy	Phase 4
Not yet recruiting	`NCT02511496` - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia	N/A
Completed	`NCT02788682` - Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy	N/A
Not yet recruiting	`NCT01949168` - A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV	Phase 2
Completed	`NCT01439776` - Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients	Phase 4
Recruiting	`NCT01360879` - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease	N/A
Recruiting	`NCT01360892` - Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography	N/A
Completed	`NCT00968357` - Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed	Phase 2
Terminated	`NCT00962936` - Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection	Phase 1/Phase 2
Recruiting	`NCT00575627` - Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels	Phase 4
Recruiting	`NCT01178749` - Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments	N/A
Completed	`NCT00537407` - A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment	Phase 2
Recruiting	`NCT00370617` - Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance	Phase 4
Completed	`NCT01684787` - Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients	Phase 4