[Federal Register Volume 64, Number 112 (Friday, June 11, 1999)]
[Notices]
[Page 31600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14824]
[[Page 31600]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) of the National Institutes of Health (NIH) Announces
the Opportunity for Clinical Trial Agreements (CTA) in Conjunction with
a Major Multicenter Clinical Trial Aimed at Developing Practical, Safe
and Effective Means of Preventing the Progression of Liver Disease in
Patients With Chronic Hepatitis C Virus (HCV) Infection
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: The National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) seeks capability statements from parties interested in
entering into a potential Clinical Trial Agreement (CTA) to provide
agent for treating subjects in the Hepatitis C Clinical Trial (HCCT).
Collaborator applicants developing capability statements must also
include plans for packaging, labeling, and distributing agent and
placebo. The primary criterion for selecting a potential Collaborator
is the scientific merit of proposals for use of preventing the
progression of liver disease in patients with chronic hepatitis C virus
infection.
The control of the HCCT shall reside entirely with the Institute
and the scientific participants of the trial. In the event that any
adverse effects are encountered which, for legal or ethical reasons,
may require communication with the FDA, the relevant collaborating
institutions will be notified. Neither the conduct of the trial nor the
results should be represented as a NIDDK endorsement of the drug under
study.
DATES: Only written Capability Statements received by the NIDDK on or
before August 1, 1999 will be considered during the initial design
phase. Potential Collaborators may be invited to meet with the
Selection Committee at the Collaborator's expense to provide additional
information. The Institute may issue an additional notice of
opportunity during the design of the trial if circumstances change or
if the trial design alters substantially.
FOR ADDITIONAL INFORMATION AND QUESTIONS: Capability statements should
be submitted to Dr. Michael W. Edwards, Office of Technology
Development, National Institute of Diabetes and Digestive and Kidney
Diseases, National Institutes of Health, BSA Building, Suite 350 MSC
2690, 9190 Rockville Pike, Bethesda, MD 20814-3800; Tel: 301/496-7778,
Fax: 301/402-0535; Email:mels@nih.gov.
SUPPLEMENTARY INFORMATION: The HCCT will be conducted as collaborative
contracts among nine (9) Clinical Centers (CCs) a central data
coordinating (DCC) with biostatistical expertise and with input from a
hepatologist, and a central virological testing laboratory (VL). The
HCCT will be designed to evaluate whether continuous long-term
antiviral therapy can slow the progression of liver disease, preventing
cirrhosis or preventing worsening of cirrhosis, decompensation,
development of hepatocellular carcinoma (HCC) and death from liver
disease. The Trial will also evaluate the natural history of hepatitis
C and the factors that predict or correlate with disease progression.
The major focus will be to evaluate whether antiviral therapy, despite
not leading to eradication of HCV, can suppress hepatocellular injury,
necrosis and fibrosis.
HCCT is expected to recruit approximately 800 patients with chronic
hepatitis C who have failed to respond to therapy with alpha interferon
(with or without ribavirin) and who have significant fibrosis on liver
biopsy. The carefully designed cohort of patients will be enrolled in a
study of the efficacy and safety of a continuous long-term antiviral
therapy (for as long as four years)
Capability Statements
The design concept described above is not final. The final design
will be developed over the course of the first year of the trial by the
HCCT Steering Committee (which will include the Principal Investigators
of the Clinical Centers, the Data Coordinating Center, the Virology
Laboratory and the NIDDK Project Officer). It is possible that the
final design for HCCT may include more than one agent.
A Selection Committee will utilize the information provided in the
``Collaborator Capability Statements'' received in response to this
announcement to help in its deliberations. The Selection Committee will
interact with the Steering Committee to develop the most appropriate
design, based on a thorough understanding of the efficacy and side
effects associated with all agents proposed.
It is the intention of the NIDDK that qualified Collaborators have
the opportunity to provide information to the Selection Committee
through their capability statements. The Capability Statement should
not exceed 8 pages and should address the following selection criteria:
(1) The statement should provide specific details regarding the
safety and efficacy of the proposed agent for long-term use in
hepatitis C patients.
(2) The statement should include a detailed plan demonstrating the
ability of the Collaborator to provide sufficient quantities of the
agent in a timely manner for the duration of the study.
(3) The statement should outline plans for packaging, labeling, and
distributing the agent along with placebo. The statement should
describe the commitment of other resources such as scientific research,
personnel, services, facilities, or equipment that would be used to
support conduct of the trial.
(4) The statement must address willingness to promptly publish
research results and ability to be bound by PHS policies.
Dated: June 4, 1999.
L. Earl Laurence,
Deputy Director, National Institute of Diabetes and Digestive and
Kidney Diseases, National Institutes of Health.
[FR Doc. 99-14824 Filed 6-10-99; 8:45 am]
BILLING CODE 4140-01-M
