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

NCT ID: NCT03549832

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-01-30

Brief Summary

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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.

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Detailed Description

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HCV management with new DAAs is now promising. However, many cases reporting treatment failure either non-responder or relapse 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 a multicenter open-labeled randomized trial.

Conditions

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HCV Coinfection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sof/sim/dac

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin

Group Type ACTIVE_COMPARATOR

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg oral pills

Simeprevir

Intervention Type DRUG

Simeprevir 150 mg oral pills

Daclatasvir

Intervention Type DRUG

Daclatasvir 60 mg oral pills

Ribavirin

Intervention Type DRUG

Ribavirin 200 mg oral pills

sof/omb/parit

Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin

Group Type ACTIVE_COMPARATOR

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400 mg oral pills

Ribavirin

Intervention Type DRUG

Ribavirin 200 mg oral pills

Ombitasvir/paritaprevir/ritonavir

Intervention Type DRUG

Ombitasvir/paritaprevir/ritonavir oral pills

Interventions

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Sofosbuvir

Sofosbuvir 400 mg oral pills

Intervention Type DRUG

Simeprevir

Simeprevir 150 mg oral pills

Intervention Type DRUG

Daclatasvir

Daclatasvir 60 mg oral pills

Intervention Type DRUG

Ribavirin

Ribavirin 200 mg oral pills

Intervention Type DRUG

Ombitasvir/paritaprevir/ritonavir

Ombitasvir/paritaprevir/ritonavir oral pills

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role collaborator

South Valley University

OTHER

Sponsor Role collaborator

Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abdelsabour Mekky

Ass. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Mekky, MD

Role: STUDY_DIRECTOR

Assiut University

Locations

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Assiut University Hopsital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 26083155 (View on PubMed)

Other Identifiers

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IRB17300204

Identifier Type: -

Identifier Source: org_study_id

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