CompletedPhase 1

Viral Kinetics in HCV Clearance in Subjects With Hemophilia

United States5 participantsStarted 2012-12

Plain-language summary

This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Hemophilia A or B
✓. HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype)
✓. Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment

Exclusion criteria

✕. Age ≥ 18 years
✕. Prior HCV treatment naïve or experienced
✕. HCV viral load detectable during screening period
✕. Absence of exclusion criteria
✕. Sexually active subjects (both male and female) must agree and commit to the use of a medically acceptable form of contraception for the duration of the study and for 6 months following the last dose of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception.
✕. Hemoglobin \<11
✕. Pregnancy (during screening period or any time during treatment)
✕. females, that are planning to become pregnant or are breastfeeding

What they're measuring

Number of Participants With Sustained Virological Response at Week 12 (SVR12)

Timeframe: Post-treatment at week 12

Trial details

NCT IDNCT01704521

SponsorKenneth Sherman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-10

Results submitted2015-02-03

View on ClinicalTrials.gov More Chronic Hepatitis C trials