WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients

This study has been terminated.
(Study never started at our site Funding issue)
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00275314
First received: January 9, 2006
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

This is a multi-center, open label, randomized, 3-way cross-over study. 21 subjects will be randomized to receive all three treatments in one of three treatment sequences.

Patients at risk of CMV disease (D+R-, D+R+, D-R+), who are being treated prophylactically with Valcyte® (commercially available tablets), after their first or second kidney transplant and who have adequate renal and hematological function will be eligible for the study. Screening may be at any time after transplantation provided that follow-up procedures can be completed during the scheduled time of prophylaxis. The first dose of study drug may be between 1 and 14 days after screening provided the transplant has stabilized, stable serum creatinine and steady-state kinetics of ganciclovir and calcineurin inhibitor therapy have been attained. Follow-up will take place 7- 14 days after last dose of study drug administration; therefore the duration of the study will be up to 5 weeks.


Condition Intervention Phase
Kidney Transplant
Drug: Valganciclovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients, Sponsor Protocol Dated 8/11/2005 and Investigator Brochure Version August 2005

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The primary objective of the study is to determine bioequivalence of ganciclovir from the
  • Valganciclovir tutti-frutti syrup formulation and the 450 mg tablet formulation at a dose of 900 mg administered in the fed state.

Secondary Outcome Measures:
  • The secondary objective is to compare the systemic exposure to ganciclovir from the
  • Valganciclovir strawberry syrup formulation with the valganciclovir tutti-frutti syrup formulation at a dose of 900mg.

Estimated Enrollment: 5
Study Start Date: February 2006
Estimated Study Completion Date: April 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has received first or second kidney transplant.
  2. Transplantation occurred at least 14 days before screening.
  3. Patient at risk of CMV disease (serostatus, D+R-, D+R+ or D-R+).
  4. Patient aged 18 to 68 years inclusive.
  5. Patient able to tolerate oral medication from screening to follow-up.
  6. Patient being treated with Valganciclovir for prophylaxis of CMV disease according to current center practice.
  7. Patient on stable calcineurin inhibitor and 900 mg Valganciclovir therapy (≥ 4 days prior to Day 1).
  8. Patient with stable serum creatinine (± 0.2 mg/dL) for duration of at least 4 days prior to dosing on Day 1.
  9. Patient with adequate hematological and renal function defined as:

    • Estimated creatinine clearance ≥ 60 ml/min
    • Absolute neutrophil count ≥ 2500 cells/µL
    • Platelet count ≥ 100,000 cells/µL
    • Hemoglobin ≥ 9.0g/dL
  10. Patient agrees to use an effective method of contraception (or abstinence from sexual activity) throughout the study period and for 90 days after follow-up, if female of child-bearing potential, or if male with a female partner of child-bearing potential.
  11. Females of childbearing potential with a negative pregnancy test at screening.
  12. Patient able to participate, willing to give written, informed consent and comply with the study restrictions.

    -

Exclusion Criteria:

  • Patients with any of the following will be excluded from the study:

    1. Patient is simultaneously participating in another clinical trial, except as approved by the Sponsor.
    2. Patient has used an investigational drug within three months of screening.
    3. Patient has exhibited in the past an allergic, or other significant adverse reaction to acyclovir, Val acyclovir, ganciclovir or Valganciclovir.
    4. Patient has severe, uncontrolled diarrhea.
    5. Evidence of graft rejection as determined by the Investigator.
    6. Patient requires the use of any prohibited concomitant medications (Section 4.4).
    7. Patient has previously participated (i.e. completed Day 1) in this clinical trial.
    8. Patient is pregnant or a lactating female who will not discontinue nursing prior to study entry.
    9. Patient has received anti-CMV prophylaxis with a treatment other than intravenous cytogam, intravenous ganciclovir or Valganciclovir between transplant and enrollment.
    10. Patient with active bacterial, viral, fungal or protozoal infection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00275314

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Hoffmann-La Roche
Investigators
Principal Investigator: David L Paterson, MD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00275314     History of Changes
Other Study ID Numbers: IRB # 0512007
Study First Received: January 9, 2006
Last Updated: December 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
transplantation

Additional relevant MeSH terms:
Ganciclovir
Valganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014