Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon
- Registration Number
- NCT02804386
- Lead Sponsor
- 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 573
- 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
- Not given informed consent
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment Sofosbuvir Sofosbuvir, 400 mg OD for 6 months
- Primary Outcome Measures
Name Time Method Sustained Viralogical response (SVR) 12 or 24 weeks after discontinuation of therapy HCV RNA LLQ \< 10 IU/Ml
- Secondary Outcome Measures
Name Time Method Viral break through and relapse after discontinuation Time duration: Up to 12 or 24 weeks 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 Level of HCV RNA within 12 or 24 weeks from baseline in HCV RNA (log10 IU/mL) \[ Time Frame: Up to 12 or 24 weeks \]
Trial Locations
- Locations (1)
Ojha, Duhs
🇵🇰Karachi, Sindh, Pakistan