CompletedPhase 1/2

CMX001 in Post-transplant Patients With BK Virus Viruria

United States29 participantsStarted 2009-11

Plain-language summary

This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus viruria.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aged between 18 to 75 years, inclusive. Males must have been able and willing to use adequate contraceptive methods throughout the study and for 3 months after the final dose. Females must have been post-menopausal, surgically sterile, or willing to use adequate contraception for the duration of the study (screening through the Day 48 visit).
✓. Were renal or hematopoietic stem cell transplant patients who met the following criteria:
✓. Renal transplant patients who:
✓. Stem cell transplant patients who:
✓. Had GFR \>30 mL/min.
✓. Were able to swallow tablets.
✓. Were willing and able to understand and provide written informed consent.
✓. Were willing and able to participate in all required study activities for the duration of the study (including ingestion of oral medication).

Exclusion criteria

✕. Females who were currently nursing or pregnant.
✕. Were using illicit drugs or abusing alcohol.
✕. Had hypersensitivity to cidofovir or brincidofovir.
✕. Had received aminoglycosides (intravenously) or NSAIDS (except as given for cardioprotective treatment) within 7 days prior to enrollment; had received leflunomide, cidofovir, or any other medication for treatment of BK virus infection or disease within 14 days prior to enrollment; had received any investigational drug (including maribavir) within 30 days prior to enrollment.
✕. Were HIV positive (results must have been obtained within 1 year prior to dosing); had active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection as evidenced by plasma levels of HCV RNA or HBV DNA, respectively.
✕. Were renal transplant patients with evidence of biopsy proven acute rejection in the 3 weeks prior to enrollment. This exclusion criterion applied only to those patients for whom a biopsy was performed within the 3 weeks prior to enrollment.
✕. Were stem cell transplant patients who:
✕. Had cystitis ≥Grade 3 National Cancer Institute, Common Terminology Criteria for Adverse Events version 3.0.

What they're measuring

Number of Adverse Events in Post-Transplant Patients With BK Virus Viruria

Timeframe: 35 days (Day 0 to Day 35)

Trial details

NCT IDNCT00793598

SponsorJazz Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

Results submitted2021-06-27

View on ClinicalTrials.gov More Viruria trials