Impact of Hepatitis C Therapy and Bone Health

Stopped early · Phase 4

Conditions studied: Human Immunodeficiency Virus, Hepatitis C

In brief

An evaluation of the impact of Elbasvir and Grazoprevir (EBR/GZR) HCV therapy on the heart risk and bone health of HCV mono-infected and HIV/HCV co-infected patients.

Key facts

Study ID

NCT03221582

Run by

Dallas VA Medical Center

People needed

6

Starts

2017-08-28

Expected to finish

2018-11-30

Last updated by the study team

2019-08-19

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• HCV antibody and HCV RNA positive
• HCV Genotype 1a, 1b, or 4
• Liver staging assessment:
• a. Cirrhosis will be defined by any of the following: i. A liver biopsy prior to day 1 of this study showing cirrhosis (F4) ii. Fibroscan within 12 calendar months of day 1 of this study showing cirrhosis with result > 12.5 kPa iii. FibroSURE performed during screening with a score > 0.75 and APRI > 2 b. Absence of cirrhosis will be defined by any of the following: i. Liver biopsy performed within 24 months of day 1 of this study showing absence of cirrhosis ii. Fibroscan performed within 12 months of day 1 of this study with a result of ≤ 12.5 kPa iii. FibroSURE score ≤ 0.48 and APRI ≤ 1 during screening
• If HIV co-infected, HAART regimen will consist of two NRTIs (abacavir, tenofovir disoproxil fumarate or tenofovir alafenamide, each in combination with lamivudine or emtricitabine) with one of the following 3rd agents:
• raltegravir
• dolutegravir
• rilpivirine HIV co-infected patients must be on their stable HAART regimen for at least 6 months, with HIV viral load < 50 c/mL at screening

You may not qualify if…

• Hepatitis B surface antigen positivity
• Decompensated cirrhosis (Child Pugh B or C)
• Any prior hepatitis C treatment
• Pregnant or nursing
• Treatment with any medication specifically contraindicated with EBR/GZR or not recommended for concomitant use as per the prescribing label (Table 2)
• Age less than 18
• Prisoners or subjects otherwise involuntarily incarcerated
• Absence of signed informed consent by patient or appropriate surrogate
• Known hypersensitivity to elbasvir or grazoprevir
• For patients with genotype 1a, one more of the following mutations on baseline NS5A genotype: M28, Q30, L31, or Y93

Where it is running

• Dallas VA Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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