- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01672983
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
30 april 2018 uppdaterad av: AbbVie (prior sponsor, Abbott)
A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This multicenter, randomized, open-label, parallel-arm, combination treatment study consisted of a Treatment and Post-treatment Phase, divided into 2 cohorts: 1) chronic HCV GT1b- infected, pegIFN/RBV treatment-exposed Japanese adults; and 2) HCV GT2-infected, pegIFN/RBV treatment-exposed Japanese adults.
The Treatment Phase evaluated the antiviral activity, safety, and pharmacokinetics of a range of ABT-450/r and ABT-267 doses for 12 to 24 weeks.
The Post-treatment Phase evaluated the evolution and persistence of viral resistance to ABT-267 and ABT-450.
Studietyp
Interventionell
Inskrivning (Faktisk)
110
Fas
- Fas 2
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- Chronic hepatitis C, genotype 1b (HCV-GT1b) or genotype 2 (HCV GT2) infection (HCV RNA level greater than 10,000 IU/mL at screening) previously treated with pegylated interferon/ribavirin (pegIFN/RBV).
- Subject's hepatitis C virus genotype is subgenotype 1b and subject was a null responder or partial responder, OR
- Subject's hepatitis C virus genotype is subgenotype 2 and subject was a null responder, partial responder, or relapser (Null responder: received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failed to achieve a 2 log10 IU/mL reduction in HCV RNA at Week 12; Partial responders: received at least 20 weeks of pegIFN/RBV for the treatment of HCV and achieved ≥ 2 log10 IU/mL reduction in HCV RNA at Week 12, but failed to achieve HCV RNA undetectable (HCV RNA < lower limit of detection [< LLOD]) at the end of treatment; Relapsers: received at least 1 course of pegIFN/RBV for the treatment of HCV and was undetectable at the end of treatment, but HCV RNA was detectable within 24 weeks of treatment follow-up).
Exclusion Criteria:
- Significant liver disease with any cause other than HCV as the primary cause
- Positive screen for drugs or alcohol.
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody.
- Use of contraindicated medications within 2 weeks of dosing
- Previous use of any investigational or commercially available anti-Hepatitis C virus agent other than pegIFN/RBV, including previous exposure to ABT-450 or ABT-267.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm 1
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
|
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Andra namn:
|
|
Experimentell: Arm 2
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
|
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Andra namn:
|
|
Experimentell: Arm 3
Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
|
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Andra namn:
|
|
Experimentell: Arm 4
Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
|
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Andra namn:
|
|
Experimentell: Arm 5
Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
|
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Andra namn:
|
|
Experimentell: Arm 6
Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
|
ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
Tidsram: 24 weeks after last dose of study drug
|
The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug).
The LLOQ for the assay was 25 IU/mL.
|
24 weeks after last dose of study drug
|
|
Number of Participants With Adverse Events (AEs)
Tidsram: TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.
|
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.
A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.
AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening.
AEs related to study drug were assessed as being either probably or possibly related by the investigator.
Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.
|
TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)
Tidsram: 12 weeks after last dose of study drug
|
The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug).
The LLOQ for the assay was 25 IU/mL.
|
12 weeks after last dose of study drug
|
|
Percentage of Participants With End of Treatment (EOT) Response
Tidsram: 12 or 24 weeks after first dose of study drug
|
The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12).
The LLOQ for the assay was 25 IU/mL.
|
12 or 24 weeks after first dose of study drug
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Takuma Matsuda, MS, AbbVie GK.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Kumada H. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology. 2015 May;61(5):1523-32. doi: 10.1002/hep.27705. Epub 2015 Mar 23.
- Schnell G, Tripathi R, Krishnan P, Beyer J, Reisch T, Irvin M, Dekhtyar T, Setze C, Rodrigues L Jr, Alves K, Burroughs M, Redman R, Chayama K, Kumada H, Collins C, Pilot-Matias T. Resistance characterization of hepatitis C virus genotype 2 from Japanese patients treated with ombitasvir and paritaprevir/ritonavir. J Med Virol. 2018 Jan;90(1):109-119. doi: 10.1002/jmv.24923. Epub 2017 Sep 22.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2012
Primärt slutförande (Faktisk)
1 maj 2014
Avslutad studie (Faktisk)
1 maj 2014
Studieregistreringsdatum
Först inskickad
27 juli 2012
Först inskickad som uppfyllde QC-kriterierna
23 augusti 2012
Första postat (Uppskatta)
27 augusti 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 april 2018
Senast verifierad
1 oktober 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- RNA-virusinfektioner
- Blodburna infektioner
- Sjukdomsegenskaper
- Leversjukdomar
- Flaviviridae-infektioner
- Hepatit, Viral, Human
- Enterovirusinfektioner
- Picornaviridae-infektioner
- Infektioner
- Smittsamma sjukdomar
- Hepatit
- Hepatit A
- Hepatit C
- Virussjukdomar
- Hepatit, kronisk
- Hepatit C, kronisk
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Proteashämmare
- Cytokrom P-450 CYP3A-hämmare
- Cytokrom P-450 enzymhämmare
- HIV-proteashämmare
- Virala proteashämmare
- Ritonavir
Andra studie-ID-nummer
- M12-536
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .