An Open Label Evaluation of the Safety and Pharmacokineti... | NCT00002015

Studies
An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

NCT00002015

Sponsor

Roche Global Development

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Phase

Not Applicable

Conditions

Cytomegalovirus Retinitis
HIV Infections

Interventions

Ganciclovir

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ICM 1788

Status Module

Record Verification Date

Apr 1996

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Ganciclovir	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

Topical acyclovir.
Consult with the Syntex study monitor for the following:
Cytokines.
Soluble CD4.
Trichosanthin (Compound Q).
Imipenem-cilastatin.
Other investigational drugs.

Patients must have the following:

Congenital or acquired immune deficiency.
Eligibility to receive ganciclovir for the treatment of life- or sight-threatening Cytomegalovirus (CMV) disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

Mild to moderate Cytomegalovirus infection that does not satisfy the clinical severity criteria.
Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.

Concurrent Medication:

Excluded:

Other myelosuppressive drugs.
Antimetabolites.
Alkylating agents.
Nucleoside analogs (topical acyclovir is allowed).
Interferons.
Foscarnet.
Consult with the Syntex study monitor for the following:
Cytokines.
Soluble CD4.
Trichosanthin (Compound Q).
Imipenem-cilastatin.
Other investigational drugs.

Patients with the following are excluded:

Mild to moderate Cytomegalovirus (CMV) infection that does not meet the clinical severity criteria.
Absolute neutrophil count (ANC) < 500 cells/mm3 or a platelet count < 25000 platelets/mm3. Note:
Exceptions may be made for patients with pre-existing neutropenia or thrombocytopenia and immediately life-threatening disease, if the investigator believes that a delay in starting ganciclovir therapy is not advisable. In such patients, the investigator should advise the parents or guardians of the risk of further bone marrow suppression and the increased risk of infection or bleeding.
Receiving excluded medications that it is not possible to discontinue.
Congenital or neonatal CMV infections without documented congenital or acquired immunodeficiency.
Demonstrated hypersensitivity to acyclovir or ganciclovir.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Univ of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Children's Hosp of Los Angeles

ID	Term
D017726	Cytomegalovirus Retinitis
D015658	HIV Infections
D012173	Retinitis
D054069	Multiple Acyl Coenzyme A Dehydrogenase Deficiency
D003586	Cytomegalovirus Infections
D000163	Acquired Immunodeficiency Syndrome

ID	Term
D015828	Eye Infections, Viral
D015817	Eye Infections
D007239	Infections
D006566	Herpesviridae Infections

ID	Term
D000212	Acyclovir
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687