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

NCT02804386 | Completed Phase 4 DMC

• 1 other identifier: PE/ZOVAL/2016/08
• Study Type: interventional
• Target: 573
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis C, Chronic

Keywords

HCV; safety; efficacy; EVR; SVR

Outcome Measures

Primary Outcomes (1)

• Sustained Viralogical response (SVR)

  HCV RNA LLQ \< 10 IU/Ml

  12 or 24 weeks after discontinuation of therapy

Secondary Outcomes (2)

• Viral break through and relapse after discontinuation

  Time duration: Up to 12 or 24 weeks

• Level of (Hepatitis C Virus) HCV RNA

  within 12 or 24 weeks from baseline

Study Arms (1)

treatment

EXPERIMENTAL

Sofosbuvir, 400 mg OD for 6 months

Drug: Sofosbuvir

Interventions

Sofosbuvir 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

Also known as: Zoval

treatment

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not given informed consent
• Pregnancy

Sponsors & Collaborators

• PharmEvo Pvt Ltd: lead

Study Sites (1)

Ojha, Duhs

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Zahid Azam, FCPS

  DUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: January 30, 2018
• Last Updated: September 17, 2018

Record last verified: 2017-10

Locations

PA (1)