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ACTIVE NOT RECRUITING Phase 2

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes

NCT03929601 · View on ClinicalTrials.gov ↗

Study Summary

The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment.

Conditions Studied

Interventions

  • DRUG Abatacept
  • DRUG Rituximab-pvvr
  • DRUG Sterile Sodium Chloride

Study Locations (19)

California

  • Childrens Hospital of Orange County — Orange
  • Stanford University — Palo Alto
  • University of California San Francisco — San Francisco

Florida

  • University of Florida — Gainesville
  • University of Miami — Maimi

Colorado

  • Barbara Davis Center for Childhood Diabetes — Aurora

Connecticut

  • Yale University — New Haven

Indiana

  • Indiana University - Riley Hospital for Children — Indianapolis

Kansas

  • The Children's Mercy Hospital — Kansas City

Massachusetts

  • Joslin Diabetes Center — Boston

Minnesota

  • University of Minnesota — Minneapolis

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2023-10-30
Est. Completion 2029-03-31
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03929601

The ClinicalTrials.gov registry entry for NCT03929601 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions — of which Abatacept is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03929601 reports 19 study locations spanning 16 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03929601 about?

NCT03929601 is a clinical study titled "Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes". The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improve...

What is the current status of trial NCT03929601?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2023-10-30. Estimated completion is 2029-03-31.

What conditions does trial NCT03929601 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03929601?

The interventions under investigation include: Abatacept (DRUG), Rituximab-pvvr (DRUG), Sterile Sodium Chloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03929601?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03929601 being conducted?

This trial has 19 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial