Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon

NCT ID: NCT02804386

Last Updated: 2018-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-01-30

Brief Summary

Title Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin with or without Interferon among Pakistani Population: A real life trial Hepatitis Eradication Accuracy Trial of Sofosbuvir (HEATS) Study Design Endpoint Classification: Safety/Efficacy Study Intervention Model: Treatment agents (non-interventional observational study): Real life clinical practice study Masking: Open Label Primary Purpose: Treatment Duration Around 12 Months Study Centre Multi centric Study

Detailed Description

Indication Chronic Hepatitis C Virus (HCV) infection (serum HCV RNA level, >10,000 IU per milliliter) with or without cirrhosis Primary Objective o Proportion of participants with sustained virologic response 12/24 weeks after discontinuation of therapy (SVR 12 or 24 weeks) [ Time Frame: Post-treatment Week 12/24 ] [ Designated as safety issue: No ]

SVR 12/24 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12/24 weeks following the last dose of study medication.

Secondary Objective o Proportion of participants experiencing viral breakthrough [ Time Frame: Up to 12 or 24 weeks ] [ Designated as safety issue: No ] Viral breakthrough is defined as HCV RNA ≥ lower limit of quantification (LLOQ) after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be post treatment), or last available on-treatment measurement with no subsequent follow-up values.

• Proportion of participants experiencing viral relapse [ Time Frame: Up to Post treatment Week 12 or 24 ] [ Designated as safety issue: No ] Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post treatment measurement.
• Proportion of participants with Early Virological Response 4 weeks after start of therapy (EVR4) [ Time Frame: Treatment Week 4 ] [ Designated as safety issue: No ]
• SVR 12/24 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12/24 weeks following the last dose of study medication.Proportion of HCV RNA within 12 or 24 weeks change from baseline in HCV RNA (log10 IU/mL) [ Time Frame: Up to 12 or 24 weeks ] [ Designated as safety issue: No ]
• Proportion of participants experiencing an adverse event (AE) leading to permanent discontinuation of study medication [ Time Frame: Baseline to Week 12 or 24 ] [ Designated as safety issue: No ] Number of Subjects 5000 patients

Dosing - Sofosbuvir 400 mg tablet taken once daily orally

• Ribavirin twice daily orally

• 1000 mg in patients with body weights <75 kg
• 1200 mg in those with weights >75 kg
• Interferon for 12 or 24 weeks Drug duration Duration and combination depends upon the discretion of Principal investigator.

Proposed Duration for Genotype:

Inclusion criteria • Men and women, 18 years of age or older,

• Treatment -Naïve and not responded with the previous therapy
• HCV Relapse
• Patient of HCV waiting for transplant, bridge to transplant
• Cirrhosis
• Not previously enrolled in any trial/study of Sofosbuvir Exclusion criteria o Not given informed consent o Pregnancy

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

Sofosbuvir, 400 mg OD for 6 months

Group Type: EXPERIMENTAL

Sofosbuvir

Intervention Type: DRUG

Sofosbuvir (formerly known as GS-7977) is a direct-acting nucleotide polymerase inhibitor that is being developed as an oral drug for the treatment of chronic HCV infection

Interventions

Sofosbuvir

Sofosbuvir (formerly known as GS-7977) is a direct-acting nucleotide polymerase inhibitor that is being developed as an oral drug for the treatment of chronic HCV infection

Intervention Type: DRUG

Other Intervention Names

Zoval

Eligibility Criteria

Inclusion Criteria

• Men and women, 18 years of age or older,
• Treatment -Naïve and not responded with the previous therapy
• Cirrhosis
• Not previously enrolled in any trial of Sofosbuvir

Exclusion Criteria

• Not given informed consent
• Pregnancy

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmEvo Pvt Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zahid Azam, FCPS

Role: PRINCIPAL_INVESTIGATOR

DUHS

Locations

Ojha, Duhs

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

PE/ZOVAL/2016/08

Identifier Type: -

Identifier Source: org_study_id