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

NCT00275314 | Terminated Phase 3

• 1 other identifier: IRB # 0512007
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Transplant

Keywords

transplantation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Interventions

Valganciclovir DRUG

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has received first or second kidney transplant.
• Transplantation occurred at least 14 days before screening.
• Patient at risk of CMV disease (serostatus, D+R-, D+R+ or D-R+).
• Patient aged 18 to 68 years inclusive.
• Patient able to tolerate oral medication from screening to follow-up.
• Patient being treated with Valganciclovir for prophylaxis of CMV disease according to current center practice.
• Patient on stable calcineurin inhibitor and 900 mg Valganciclovir therapy (≥ 4 days prior to Day 1).
• Patient with stable serum creatinine (± 0.2 mg/dL) for duration of at least 4 days prior to dosing on Day 1.
• 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
• 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.
• Females of childbearing potential with a negative pregnancy test at screening.

You may not qualify if:

• Patients with any of the following will be excluded from the study:
• Patient is simultaneously participating in another clinical trial, except as approved by the Sponsor.
• Patient has used an investigational drug within three months of screening.
• Patient has exhibited in the past an allergic, or other significant adverse reaction to acyclovir, Val acyclovir, ganciclovir or Valganciclovir.
• Patient has severe, uncontrolled diarrhea.
• Evidence of graft rejection as determined by the Investigator.
• Patient requires the use of any prohibited concomitant medications (Section 4.4).
• Patient has previously participated (i.e. completed Day 1) in this clinical trial.
• Patient is pregnant or a lactating female who will not discontinue nursing prior to study entry.
• Patient has received anti-CMV prophylaxis with a treatment other than intravenous cytogam, intravenous ganciclovir or Valganciclovir between transplant and enrollment.
• Patient with active bacterial, viral, fungal or protozoal infection.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• David L Paterson, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 9, 2006
• First Posted: January 11, 2006
• Study Start: February 1, 2006
• Study Completion: April 1, 2006
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

US (1)