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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804386
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
PharmEvo Pvt Ltd

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

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Sofosbuvir Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 573 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (Hepatitis Eradication Accuracy Trial of Sofosbuvir): An Observational Non-interventional Real Life Trial
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: treatment
Sofosbuvir, 400 mg OD for 6 months
Drug: 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
Other Name: Zoval




Primary Outcome Measures :
  1. Sustained Viralogical response (SVR) [ Time Frame: 12 or 24 weeks after discontinuation of therapy ]
    HCV RNA LLQ < 10 IU/Ml


Secondary Outcome Measures :
  1. Viral break through and relapse after discontinuation [ Time Frame: Time duration: Up to 12 or 24 weeks ]
    Viral break through and relapse after discontinuation [Time duration: Up to 12 or 24 weeks]

  2. Level of (Hepatitis C Virus) HCV RNA [ Time Frame: within 12 or 24 weeks from baseline ]
    Level of HCV RNA within 12 or 24 weeks from baseline in HCV RNA (log10 IU/mL) [ Time Frame: Up to 12 or 24 weeks ]



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804386


Locations
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Pakistan
Ojha, Duhs
Karachi, Sindh, Pakistan
Sponsors and Collaborators
PharmEvo Pvt Ltd
Investigators
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Principal Investigator: Zahid Azam, FCPS DUHS
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Responsible Party: PharmEvo Pvt Ltd
ClinicalTrials.gov Identifier: NCT02804386    
Other Study ID Numbers: PE/ZOVAL/2016/08
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by PharmEvo Pvt Ltd:
HCV
safety
efficacy
EVR
SVR
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents