A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/r With or Without Dasabuvir and With or Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 or 4 Infected Adults With Successfully Treated Early Stage Hepatocellular Carcinoma

Chronic Hepatitis C Infection Clinical Trial

— GEODE - I  

Official title:

Open-label Study to Evaluate the Safety and Efficacy of the Combination of Ombitasvir, Paritaprevir/r ± Dasabuvir With or Without Ribavirin (RBV) in Adult Patients With GT1 or GT4 Chronic HCV Infection and Response to Prior Treatment of Early Stage Hepatocellular Carcinoma (GEODE - I)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02504099
• Other study ID #: M14-726
• Secondary ID: 2015-001049-10
• Status: Terminated
• Phase: Phase 3
• First received: July 20, 2015
• Last updated: November 13, 2017
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), with or without dasabuvir (DSV) coadministered with or without ribavirin (RBV) for 12 or 24 weeks in adult patients with genotype 1 or genotype 4 chronic HCV infection and treated early stage Hepatocellular Carcinoma with compensated cirrhosis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, at least 18 years of age at time of screening

2. Chronic hepatitis C virus (HCV) infection prior to study enrollment with screening laboratory results indicating HCV genotype 1 or 4 infection

3. Early stage hepatocellular carcinoma (HCC) diagnosed based on the typical hallmark of HCC (hypervascular in the arterial phase with washout in the portal venous or delayed phases)

4. Compensated cirrhosis defined as a Child-Pugh score of 5 or 6 at Screening

• A minimal rim of ascites if detected at imaging is acceptable. Exclude ascites that requires the need to apply diuretic treatment to control ascites

5. Documented complete response to HCC treatment.

6. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control.

Exclusion Criteria:

1. Use of known strong or moderate inducers of cytochrome P450 3A (CYP3A) in participants receiving ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) with and without dasabuvir (DSV), strong inducers and inhibitors (e.g., gemfibrozil) of cytochrome P450 2C8 (CYP2C8) in participants receiving OBV/PTV/r with DSV, medications contraindicated for ritonavir or RBV (for those that receive RBV) within 2 weeks or 10 half-lives (if known), whichever is longer, prior to study drug . For medications contraindicated with AbbVie's 2-direct-acting antiviral agent (2-DAA) and 3-DAA regimen, refer to the recommended prescribing information section of the approved local product labels.

2. Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).

3. Patients regardless of eligibility to liver transplant, who have a comorbid disease that might preclude completion of study follow-up.

4. Clinically significant abnormalities, other than HCV infection, in a participant with HCC based upon the medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG) that make the participant an unsuitable candidate for this study in the opinion of the investigator.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• ombitasvir/paritaprevir/ritonavir and dasabuvir
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
• ombitasvir/paritaprevir/ritonavir
Tablet; ombitasvir coformulated with paritaprevir and ritonavir
• ribavirin
Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)	SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [	12 weeks after the last actual dose of study drug
Secondary	Percentage of Participants With On-treatment Virologic Failure	On-treatment virologic failure was defined as confirmed HCV RNA = LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA = LLOQ throughout treatment with at least 6 weeks of treatment.	Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 12-week treatment)
Secondary	Percentage of Participants With Post-treatment Relapse	Post-treatment relapse was defined as confirmed HCV RNA = LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.	From the end of treatment through 12 weeks after the last dose of study drug
Secondary	Percentage of Participants With Long Term Clinical Outcomes	The percentage of participants with long term clinical outcomes (de novo hepatocellular carcinoma (HCC) lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above) from first dose of study drug through 24 weeks post-treatment follow-up.	up to 48 weeks
Secondary	Percentage of Participants With Recurrent HCV Infection Post Liver Transplant	The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.	from liver transplant to 24 weeks post-treatment (up to 48 weeks)

External Links

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