A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)
13. august 2014 opdateret af: Bristol-Myers Squibb
The purpose of this study is to determine the rate of kidney or heart impairment, if any, in subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
113
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90036
- Local Institution
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Minnesota
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St. Paul, Minnesota, Forenede Stater, 55114
- Prism Research
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37920
- New Orleans Center For Clinical Research - Knoxville
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Texas
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San Antonio, Texas, Forenede Stater, 78215
- Local Institution
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San Juan, Puerto Rico, 00927
- Local Institution
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects who participated in prior trial with BMS-986094/INX-08189 and received at least 1 dose of INX-08189 or placebo in trials INH-189-002 or INH-189-006
Beskrivelse
Inclusion Criteria:
Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and:
- Received at least 1 dose of INX-08189 or
- Received placebo in studies for HCV-infected subjects (INH-189-002 or INH-189-006)
- Age 18 or older
Exclusion Criteria:
-
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Subjects treated with BMS-986094/INX-08189
Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered
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Andre navne:
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Subjects treated with Placebo matching BMS-986094/INX-08189
Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered
|
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Rate of renal impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired renal function and require referral to a nephrologist
Tidsramme: Up to Day 90
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Up to Day 90
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Rate of cardiac impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired cardiac function and require referral to a cardiologist
Tidsramme: Up to Day 90
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Up to Day 90
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Changes in the electrocardiographic parameters observed in association with prior exposure to single and multiple oral doses of BMS-986094 compared to pre-exposure electrocardiograms (ECGs)
Tidsramme: Baseline (pre-dose Day 1 ECG from parent study) and By Day 30
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Baseline (pre-dose Day 1 ECG from parent study) and By Day 30
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Abnormalities in cardiac ejection fraction (EF) as determined by trans-thoracic echocardiogram that may be associated with prior exposure to single or multiple oral doses of BMS-986094
Tidsramme: By Day 90
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By Day 90
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Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094
Tidsramme: By Day 30
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By Day 30
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Changes in serum creatinine levels compared to pre-exposure levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094
Tidsramme: Baseline (Day 1 from parent study) and By Day 14
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Baseline (Day 1 from parent study) and By Day 14
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Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094
Tidsramme: By Day 7
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By Day 7
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Presence of signs, symptoms or medical history suggestive of heart failure or renal failure that may have been observed since last exposure to BMS-986094
Tidsramme: By Day 90
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By Day 90
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Abnormalities in creatine phosphokinase (CPK) and creatine phosphokinase-metabolic (CPK-MB) levels that may be associated with prior exposure to single or multiple doses of BMS-986094
Tidsramme: By Day 30
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By Day 30
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Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094
Tidsramme: By Day 30
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By Day 30
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2012
Primær færdiggørelse (Faktiske)
1. juni 2014
Studieafslutning (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først indsendt
20. november 2012
Først indsendt, der opfyldte QC-kriterier
23. november 2012
Først opslået (Skøn)
26. november 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AI472-013
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