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

HCV Coinfection Clinical Trial

Official title:

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549832
• Other study ID #: IRB17300204
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coinfection
• HCV Coinfection

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg oral pills
• Simeprevir
Simeprevir 150 mg oral pills
• Daclatasvir
Daclatasvir 60 mg oral pills
• Ribavirin
Ribavirin 200 mg oral pills
• Ombitasvir/paritaprevir/ritonavir
Ombitasvir/paritaprevir/ritonavir oral pills

Locations

Country	Name	City	State
Egypt	Assiut University Hopsital	Assiut

Sponsors (3)

Lead Sponsor	Collaborator
Assiut University	Sohag University, South Valley University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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