- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02442271
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil
5. juli 2017 oppdatert av: AbbVie
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve or Treatment-Experienced Adults in Brazil With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ III)
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
222
Fase
- Fase 3
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
- Males must be surgically sterile or agree to practice acceptable forms of birth control
- Chronic hepatitis C virus (HCV) infection at screening
- Fibrosis stage F3 or greater, documented by acceptable tests
- Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
- Use of contraindicated medications within 2 weeks of dosing
- Clinically significant abnormalities or co-morbidities
- History of solid organ transplant
- Abnormal laboratory tests
- Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 3-DAA ± RBV
3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Tablett; ombitasvir samformulert med paritaprevir og ritonavir, dasabuvir tablett
Andre navn:
Tablett
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Tidsramme: 12 weeks after the last actual dose of study drug
|
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Participants with missing data were counted as failures.
|
12 weeks after the last actual dose of study drug
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With SVR12 by Fibrosis Stage
Tidsramme: 12 weeks after the last actual dose of study drug
|
SVR12 was defined as plasma HCV RNA level <LLOQ]12 weeks after the last dose of study drug.
The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented.
Participants with missing data were counted as failures.
|
12 weeks after the last actual dose of study drug
|
Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience
Tidsramme: 12 weeks after the last actual dose of study drug
|
SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
Data are presented by prior HCV treatment experience.
Data are provided by participants' prior HCV treatment experience at screening.
Participants with missing data were counted as failures.
|
12 weeks after the last actual dose of study drug
|
Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening
Tidsramme: 12 weeks after the last actual dose of study drug
|
SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug.
Data are presented by prior HCV treatment experience.
Data are provided by participants' eligibility for treatment with IFN at screening.
Participants with missing data were counted as failures.
|
12 weeks after the last actual dose of study drug
|
Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
Tidsramme: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
|
The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score.
Scores range from 0 to 100.
A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening.
If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.
|
Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
|
Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
Tidsramme: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
|
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument.
The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks.
Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score.
SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening.
If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain.
In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing.
The SF-36v2 MCS and PCS scores were not computed if any domain
|
Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
|
(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
Tidsramme: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
|
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument.
The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks.
Domain scores are aggregated into a PCS score and a MCS score.
Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening.
If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain.
In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing.
The SF-36v2 MCS and PCS scores were not computed if any domain was missing.
|
Day 1 (Baseline), 12 weeks after the last actual dose of the study drug
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
27. april 2015
Primær fullføring (Faktiske)
4. juli 2016
Studiet fullført (Faktiske)
26. september 2016
Datoer for studieregistrering
Først innsendt
11. mai 2015
Først innsendt som oppfylte QC-kriteriene
11. mai 2015
Først lagt ut (Anslag)
13. mai 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. august 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. juli 2017
Sist bekreftet
1. juli 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- RNA-virusinfeksjoner
- Virussykdommer
- Blodbårne infeksjoner
- Sykdomsattributter
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Infeksjoner
- Smittsomme sykdommer
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
- Hepatitt, kronisk
- Hepatitt C, kronisk
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Anti-HIV-midler
- Antiretrovirale midler
- Antimetabolitter
- Proteasehemmere
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- HIV-proteasehemmere
- Virale proteasehemmere
- Ribavirin
- Ritonavir
Andre studie-ID-numre
- M14-225
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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