Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03222167
• Date of registration: 17/07/2017
• Prospective Registration: Yes
• Primary sponsor: Institute Of Cardiology & Internal Diseases, Kazakhstan
• Public title: Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b
• Scientific title: Open-Label Multi-Center Single Arm Clinical Trial to Study the Efficacy and Safety of the Elbasvir/ Grazoprevir 50/100 mg Fixed Dose Combination Once Daily in Patients With Chronic HCV GT1b Infection Associated With Metabolic Syndrome
• Date of first enrolment: October 2017
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03222167
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Kazakhstan

Contacts

• Name: Alexandre V. Nersesov, MD, Prof.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Be 18-70 years of age on a day of signing of informed consent.

2. Have =40 kg/m2.

3. Have HCV RNA = 10,000 IU/mL at the time of screening.

4. Have documented chronic HCV GT1b (with no evidence of non-typeable or mixed genotype)
infection (positive for anti-HCV antibody, HCV RNA, or HCV GT1b at least 6 months
before screening).

5. Have liver disease staging assessment by means of liver biopsy performed within 12
calendar months prior to Day 1 of this study or Fibroscan performed within 6 calendar
months prior to Day 1 of this study (cut-off of 12.5 kPa has a positive predictive
value of 90% and a sensitivity of 95% for =F3).

6. Be HIV and HBV negative.

7. Be naïve to all anti-HCV treatment.

8. Have provided written informed consent for the trial.

9. Be diagnosed with metabolic syndrome (according to guidelines from the National Heart,
Lung, and Blood Institute (NHLBI) and the American Heart Association (AHA)), i.e. have
central obesity (defined as waist circumference in Asian males >94 cm, in Caucasian
males >90 cm, in females > 80 cm) combined with at least any of two of the following
factors: (1) raised triglycerides =150 mg/dL (1.7 mmol/L) or specific treatment for
this lipid abnormality; (2) reduced HDL cholesterol < 40 mg/dL (1.03 mmol/L) in males
or < 50 mg/dL (1.29 mmol/L) in females or specific treatment for this lipid
abnormality; (3) raised blood pressure - systolic BP =130 or diastolic BP = 85 mm Hg
or treatment of previously diagnosed hypertension; (4) raised fasting plasma glucose
(FPG) =100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes.

10. Reproductive potential patient agrees to avoid becoming pregnant or impregnating a
partner until at least 6 months after the last dose of medication.

Exclusion Criteria:

1. Is below 18 years of age.

2. Has not signed Informed Consent Document.

3. Has HCV genotype other than genotype 1b.

4. Has BMI > 40 kg/m2.

5. Has history of clinically significant psychiatric disorder which in the opinion of the
investigator, would interfere with the study procedures and compliance.

6. Has received Peg/RBV, Telaprevir, or Boceprevir, or Sofosbuvir, or any other oral
anti-HCV treatment/ combinations

7. Has documented portal hypertension and hepatic decompensation (Child-Pugh B or C,
esophageal varices, ascites, elevated bilirubin, jaundice, splenomegaly, hepatic
encephalopathy, albumin below 3 g/dl; platelet count < 75 000, INR<1.7), history of
liver decompensation.

8. Has history of liver or other organ transplant.

9. Has autoimmune hepatitis.

10. Has ALT > 10 x ULN.

11. Is co-infected with hepatitis B virus (e.g., HBsAg positive) and HIV.

12. Has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC (if
liver imaging within 6 months of Day1 is not available, imaging is required during the
screening).

13. Has a clinically-relevant drug or alcohol abuse within 12 months of screening.

14. Has decompensated DM with HbA1 >12%.

15. Has a medical/surgical condition that may result in a need for hospitalization during
the period of the study.

16. Is a female who is pregnant or breast-feeding, or expecting to become pregnant and
continue throughout treatment and follow up, OR male who plan to impregnate or has a
female sexual partner of childbearing potential, or pregnant, or unwilling to commit
to using a two methods of birth control throughout treatment and after the completion
of all treatment and follow-up.

17. Is currently participating or has participated in a study with an investigational
compound within 30 days

18. Is taking or plan to take any of the prohibited medications or herbal supplements:
co-administration with the following drugs: Didanosine, Nafcillin, Rifampin Phenytoin,
Bosentan, Modafinil, Phenobarbital, Carbamazepine, St. John's Wort (Hypericum
perforatum), Glibenclamid, Glyburide, Gemfibrozil, Eltrombopag, Lapatinib, Efavirenz,
Atazanavir, Darunavir, Lopinavir, Saquinavir, Tipranavir, Cyclosporine, Simvastatin,
Fluvastatin, Rosuvastatin greater than 10 mg dose, Atorvastatine greater than 10 mg
dose, hepatotoxic drugs. Any condition that requires administration of systemic
corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course
of the study.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Cirrhoses, Liver

Fibrosis, Liver

Chronic Hepatitis C Genotype 1B

Intervention(s)

Drug: Elbasvir/ Grazoprevir 50/100 mg fixed dose combination

Primary Outcome(s)

SVR12 evaluation [Time Frame: 12 weeks after the end of all study therapy (treatment success).]

Secondary Outcome(s)

Death/Lost [Time Frame: 24 weeks]

Secondary ID(s)

ICID.HCV.0117

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck Sharp & Dohme Corp.

Synergy Research Group