Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure

NCT03549832 | Completed DMC

• 1 other identifier: IRB17300204
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.

Conditions

HCV Coinfection

Keywords

HCV; DAAs; Non-responder

Outcome Measures

Primary Outcomes (1)

• SVR rate

  The primary endpoint was the achievement of SVR at week 12 (SVR12) post-treatment. The potential adverse events were evaluated in each visit for the development of adverse events or any significant interactions.

  12 weeks

Study Arms (2)

sof/sim/dac

ACTIVE COMPARATOR

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin

Drug: Sofosbuvir; Drug: Simeprevir; Drug: Daclatasvir; Drug: Ribavirin

sof/omb/parit

ACTIVE COMPARATOR

Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin

Drug: Sofosbuvir; Drug: Ribavirin; Drug: Ombitasvir/paritaprevir/ritonavir

Interventions

Sofosbuvir DRUG

Sofosbuvir 400 mg oral pills

sof/omb/parit; sof/sim/dac

Simeprevir DRUG

Simeprevir 150 mg oral pills

sof/sim/dac

Daclatasvir DRUG

Daclatasvir 60 mg oral pills

sof/sim/dac

Ribavirin DRUG

Ribavirin 200 mg oral pills

sof/omb/parit; sof/sim/dac

Ombitasvir/paritaprevir/ritonavir DRUG

Ombitasvir/paritaprevir/ritonavir oral pills

sof/omb/parit

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with proven CHC genotype 4
• years old or more,
• prior HCV treatment failure to sofosbuvir /daclatasvir
• compensated liver disease.

You may not qualify if:

• Patients with combined HCV/HBV co-infection, hepatocellular carcinoma (HCC), decompensated liver cirrhosis (Child-Pugh score above 6), and non-genotype 4 were excluded.

Sponsors & Collaborators

• Assiut University: lead
• Sohag University: collaborator
• South Valley University: collaborator

Study Sites (1)

Assiut University Hopsital

Asyut, 71515, Egypt

Location

Related Publications (1)

• Gutierrez JA, Lawitz EJ, Poordad F. Interferon-free, direct-acting antiviral therapy for chronic hepatitis C. J Viral Hepat. 2015 Nov;22(11):861-70. doi: 10.1111/jvh.12422. Epub 2015 Jun 17.

  PMID: 26083155 RESULT

MeSH Terms

Interventions

Sofosbuvir; Simeprevir; daclatasvir; Ribavirin; ombitasvir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides; Nucleosides

Study Officials

• Mohamed Mekky, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Professor

Study Record Dates

• First Submitted: May 27, 2018
• First Posted: June 8, 2018
• Study Start: January 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)