At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 57 enrolled

Drug / intervention

30,000 units hrINF-alpha +2 moredrug

Likely dose

30,000 units hrINF-alphafrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00024518

NCT00024518Phase 2Completed

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Ingested Interferon-Alpha: Prolongation or Permanence of the "Honeymoon" Phase in Newly Diagnosed Diabetes Mellitus

The University of Texas Health Science Center, Houston·interventional·Posted Sep 19, 2001·Updated Nov 19, 2013

In Brief

A Phase 2 clinical trial evaluating 30,000 units hrINF-alpha, 5,000 hrINF-alpha, and 1 other intervention for Insulin-Dependent Diabetes Mellitus. Completed, enrolled 57 participants across 5 sites.

Detailed Summary

This study will see if interferon-alpha given early in the disease can stop or slow the immune attack on insulin-producing cells. In addition, the study will examine the safety and efficacy of interferon-alpha (given by mouth) to protect beta cell function. Patients between 3 and 25 years of age with Type 1 Diabetes Mellitus less then six weeks may be eligible for this study. All study-related tests and medications at the NIH Clinical Center are provided at no cost.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInsulin-Dependent Diabetes Mellitus

CountriesUnited States

CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished

200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartSep 2001

First PostedSep 2001

Primary CompletionSep 2008

TodayJul 2026

First PostedSep 19, 2001

Enrollment StartSep 1, 2001

Primary CompletionSep 1, 2008

TodayJul 2, 2026

Enrollment to primary: 7 yearsPosted 24.8 years ago

Interventions

30,000 units hrINF-alphadrug

5,000 hrINF-alphadrug

Placeboother

placebo was prepared as saline alone with 6mg human serum albumin (HSA).