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Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus Genotype 2K/1B

8 augusti 2019 uppdaterad av: HaEmek Medical Center, Israel

An Open-Label, Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus (HCV) Infection Genotype 2K/1B- NINJA Study

HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution.

Since different HCV genotypes react differently on available antiviral therapies, the correct identification of HCV genotype serves as a marker of responsiveness and an indicator for duration of treatment.

The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002.

A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these findings, the number of patients with 2k/1b may be underestimated.

AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3 DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV proteins essential for viral replication. The high efficacy of the 3D regimen was proven in registration clinical trials and RW for 1b population.

3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective

• Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b.

Study Design:

.The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of treatment and extra 24 weeks of follow up. Scheduled visits will include: physician assessment and blood tests including HCV resistance mutations.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Study Procedures:

Initial screening period:

HCV GT2K/1B -infected subjects who will be meeting eligibility criteria, will provide written informed consent, perform baseline RAS testing and will be enrolled to the study.

Baseline period:

On day 0, all patients will be assessed by a general physical examination, blood and urine tests including HCV resistance mutations (elaborated in the budget file), Fibroscan or SHEAR WAVE Elastography and abdominal ultrasound. After the initial assessment all included will be allocated for treatment.

Study configuration:

The study will include 1 group of patients infected GT 2k1b. Patients will be treated according to label recommendation for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Scheduled visits will take place in 0, 4, 12 and 24 weeks for all patients.

All visits will include: physician assessment and blood tests as elaborated in the Study Flowchart. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants.

Studietyp

Interventionell

Inskrivning (Faktisk)

7

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Israel
      • Afula, Israel
        • Haemek Medical Center

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 och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 18 years or older
  • Male and female
  • HCV Genotype 2K/1B (P/R experienced or naïve; non-cirrhotic/ Comp. cirrhotic CP-A 5)
  • Capable to provide informed consent

Exclusion Criteria:

  • Could not remain in the study for 36 weeks
  • Co-infected with human immunodeficiency virus (HIV) or HBV
  • Severe renal impairment (calculated creatinine clearance <30 mL/min )
  • Evidence of hepatocellular carcinoma (HCC)
  • Severe concurrent disease
  • Pregnant, lactating, expecting to conceive or donate eggs or male participant with pregnant female partner
  • DAA treatment experienced
  • History of drug or alcohol abuse within 6 months prior enrolment - positive result of a urine drug screen at the screening visit and a positive result on the alcohol consumption questioner.
  • Evidence or history of chronic liver disease not caused by HCV Participants currently enrolled in an HCV-related research protocol OR currently receiving HCV treatment

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: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment
The study will include 1 group. Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (VEKIRAX) and Dasabuvir (EXVIERA).
Läkemedel: VEKIRAX

Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (Viekirax).

Study Regimen: ombitasvir+paritaprevir+ritonavir (25+150+100mg once daily)

Andra namn:
  • Ombitasvir+Paritaprevir+Ritonavir
Läkemedel: EXVIERA

Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Dasabuvir (Exviera).

Study Regimen: dasabuvir (250 mg twice daily)

Andra namn:
  • Dasabuvir

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
The percentage of patients achieving SVR12 (single last HCV RNA <12 IU/mL 12 weeks after the last actual dose of the ABBVIE regimen)
Tidsram: 12 weeks post treatment
12 weeks post treatment

Sekundära resultatmått

Resultatmått
Tidsram
Safety: absolute and relative numbers of discontinuations, AE and SAEs (Number of Participants With Adverse Events That Are Related to Treatment).
Tidsram: 36 weeks
36 weeks
Resistance Associated Substitute (RAS): The percentage of patients with the presence of RAS's- at baseline and at post-treatment weak 12.
Tidsram: 12 weeks post treatment
12 weeks post treatment
Time of virologic failure using population sequencing; SVR12 rate
Tidsram: 36 weeks
36 weeks
Time of virologic failure using population sequencing; presence of BL RAS's.
Tidsram: 36 weeks
36 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

HaEmek Medical Center, Israel

Samarbetspartners

AbbVie

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 (Faktisk)

22 juni 2017

Primärt slutförande (Faktisk)

16 november 2017

Avslutad studie (Faktisk)

28 november 2018

Studieregistreringsdatum

Först inskickad

11 december 2016

Först inskickad som uppfyllde QC-kriterierna

8 februari 2017

Första postat (Faktisk)

13 februari 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 augusti 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 augusti 2019

Senast verifierad

1 augusti 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NINJA Study - 11227

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Obeslutsam

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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