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Trial record 5 of 1164 for:    MYCOPHENOLIC ACID

Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids

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ClinicalTrials.gov Identifier: NCT02630563
Recruitment Status : Terminated (Due to extremely slow recruitment, infrequent use of combination triple therapy (MMF, cyclosporine, steroids), study was discontinued; Part 2 was not conducted.)
First Posted : December 15, 2015
Results First Posted : April 12, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pediatric Liver Transplantation
Interventions Drug: Corticosteroids
Drug: Cyclosporine
Drug: mycophenolate mofetil
Enrollment 9
Recruitment Details The study was conducted between 02 May 2003 and 20 January 2005. This study was conducted at 2 sites in United States (US). Overall, 9 participants entered the study.
Pre-assignment Details Thirty five participants were screened; 9 entered the study following a screening period of up to 14 days. Stable pediatric liver transplant participants who were at least 6 months post-transplant and who were receiving stable dose of Mycophenolate Mofetil (MMF) in combination with cyclosporine were enrolled into the study.
Arm/Group Title Drug MMF
Hide Arm/Group Description Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Administrative             1
Arm/Group Title Drug MMF
Hide Arm/Group Description Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
All Patient Population included all participants who were enrolled in the trial
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
1.3  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
5
  55.6%
Male
4
  44.4%
1.Primary Outcome
Title Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours of Mycophenolic Acid Normalized for Dose And for Body Surface Area
Hide Description The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC0-12h was normalized to 600 milligram per square meter (mg/m^2) and 1.5 gram. AUC was reported in microgram hour per milliliter (mcg*h/mL).
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) population included all randomized and replaced participants adherent to the PK section of the protocol.
Arm/Group Title Drug MMF
Hide Arm/Group Description:
Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
Normalized to 600mg/m^2 65.6  (56.2)
Normalized to 1.5g 363  (360)
2.Secondary Outcome
Title Area Under the Plasma Concentration Time Curve From 0-12 Hours for Mycophenolic Acid and Mycophenolic Acid Glucuronide Phenolic Glucuronide of Mycophenolic Acid
Hide Description The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC was reported in microgram hour per milliliter (mcg*h/mL).
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all randomized and replaced participants adherent to the PK section of the protocol
Arm/Group Title Drug MMF
Hide Arm/Group Description:
Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mcg*h/mL
MPA Raw 29  (20.3)
MPAG Raw 487  (185)
MPAG (MPA Equivalents) 289  (109)
3.Secondary Outcome
Title Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide
Hide Description The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was obtained directly from the measured plasma concentration-time curves.
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population was used for the analysis.
Arm/Group Title Drug MMF
Hide Arm/Group Description:
Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mcg/mL
MPA Raw 7.98  (3.69)
MPAG Raw 54.6  (26.8)
MPAG (MPA Equivalents) 32.4  (15.9)
4.Secondary Outcome
Title Time to Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide
Hide Description Tmax is the amount of time after dosing to when the maximum concentration of MPA and MPAG was achieved.
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population was used for the analysis.
Arm/Group Title Drug MMF
Hide Arm/Group Description:
Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: hour
MPA Raw
1.35
(0.5 to 2.03)
MPAG Raw
1.99
(1.52 to 4.13)
5.Secondary Outcome
Title Number of Participants With Adverse Events and Serious Adverse Events
Hide Description An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.
Time Frame Up to Day 32
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who were enrolled in the trial
Arm/Group Title Drug MMF
Hide Arm/Group Description:
Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Participants with AE 1
Participants with SAE 0
6.Secondary Outcome
Title Plasma Concentration of Mycophenolic Acid and Its Metabolite Mycophenolic Acid Glucuronide at Each Time Point
Hide Description Mycophenolic Acid Glucuronide (MPAG) is an active metabolite of Mycophenolic Acid (MPA).
Time Frame Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included all randomized and replaced participants adherent to the PK section of the protocol.
Arm/Group Title Drug MMF
Hide Arm/Group Description:
Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: mcg/mL
Raw MPA at 0.0 0.786  (0.681)
Raw MPA at 0.50 9.03  (4.34)
Raw MPA at 0.75 5.67  (3.14)
Raw MPA at 1.00 5.84  (3.13)
Raw MPA at 1.50 6.16  (5.08)
Raw MPA at 2.00 6.23  (4.54)
Raw MPA at 4.00 1.89  (1.90)
Raw MPA at 8.00 1.38  (1.72)
Raw MPA at 12.00 0.676  (0.795)
Raw MPAG at 0.00 26.2  (20.4)
Raw MPAG at 0.50 26.5  (1.13)
Raw MPAG at 0.75 45.8  (28.2)
Raw MPAG at 1.00 37.2  (4.81)
Raw MPAG at 1.50 43.2  (12.9)
Raw MPAG at 2.00 51.0  (27.9)
Raw MPAG at 4.00 46.3  (21.3)
Raw MPAG at 8.00 19.2  (13.4)
Raw MPAG at 12.00 14.6  (7.35)
Time Frame Up to Day 32
Adverse Event Reporting Description All participants enrolled were included in the safety analysis.
 
Arm/Group Title Drug MMF
Hide Arm/Group Description Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
All-Cause Mortality
Drug MMF
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Drug MMF
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Drug MMF
Affected / at Risk (%)
Total   1/9 (11.11%) 
General disorders   
Pyrexia  1  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.0)
Part I of the study was terminated early with 9 participants enrolled (8 of which were evaluable for PK), and Part II of the study was not performed due to extremely slow recruitment and the infrequent use of the combination of triple therapy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
Name/Title: F. Hoffmann-La Roche AG
Organization: Roche Trial Information Hotline
Phone: +41 61 6878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02630563     History of Changes
Other Study ID Numbers: PA16497
First Submitted: December 11, 2015
First Posted: December 15, 2015
Results First Submitted: March 14, 2016
Results First Posted: April 12, 2016
Last Update Posted: May 19, 2016