- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02804386
Efficacy and Safety of Zoval (Sofosbuvir) and Ribavirin With or Without Interferon (HEATS)
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
Studieoversigt
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Sindh
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Karachi, Sindh, Pakistan
- Ojha, Duhs
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: treatment
Sofosbuvir, 400 mg OD for 6 months
|
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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sustained Viralogical response (SVR)
Tidsramme: 12 or 24 weeks after discontinuation of therapy
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HCV RNA LLQ < 10 IU/Ml
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12 or 24 weeks after discontinuation of therapy
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Viral break through and relapse after discontinuation
Tidsramme: Time duration: Up to 12 or 24 weeks
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Viral break through and relapse after discontinuation [Time duration: Up to 12 or 24 weeks]
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Time duration: Up to 12 or 24 weeks
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Level of (Hepatitis C Virus) HCV RNA
Tidsramme: within 12 or 24 weeks from baseline
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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 ]
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within 12 or 24 weeks from baseline
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Zahid Azam, FCPS, DUHS
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- RNA-virusinfektioner
- Virussygdomme
- Infektioner
- Blodbårne infektioner
- Overførbare sygdomme
- Leversygdomme
- Flaviviridae infektioner
- Hepatitis, viral, menneskelig
- Hepatitis, kronisk
- Hepatitis
- Hepatitis C
- Hepatitis C, kronisk
- Anti-infektionsmidler
- Antivirale midler
- Sofosbuvir
Andre undersøgelses-id-numre
- PE/ZOVAL/2016/08
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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