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NCT01895361 · ClinicalTrials.gov registry record · Phase 2

Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

A Phase 2 study of Sickle Cell Disease, sponsored by Reprixys Pharmaceutical Corporation.

Completed
Registry status
Phase 2
Development phase
198
Enrollment target
20
Study locations

NCT01895361 is a Phase 2 study of Sickle Cell Disease that has completed, run by Reprixys Pharmaceutical Corporation. The registered enrollment target is 198 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT01895361, a Phase 2 study of Sickle Cell Disease, has completed, sponsored by Reprixys Pharmaceutical Corporation.

COMPLETED
Registry status
Phase 2
Development phase
198 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the drug and how long it stayed in the blood stream. Funding Source - FDA Office of Orphan Products Development (OOPD)

Conditions Studied

Sickle Cell Disease

Interventions

  • DRUG Placebo
  • DRUG SelG1

Study Locations (20)

Florida

  • - Daytona Beach
  • - Jacksonville
  • - Miami
  • - Orlando
  • - Tampa

California

  • - Los Angeles
  • - Oakland
  • - Orange
  • - Sacramento

Alabama

  • - Birmingham
  • - Mobile

Georgia

  • - Atlanta
  • - Augusta

Illinois

  • - Chicago
  • - Peoria

Arkansas

  • - Little Rock

Colorado

  • - Aurora

Connecticut

  • - New Haven

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2013-07
Est. Completion 2016-03
Phase Phase 2

Sponsor

Reprixys Pharmaceutical Corporation

1 total trials

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What the Registry Record Tells You About NCT01895361

The ClinicalTrials.gov registry entry for NCT01895361 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (32% lower). The listed sponsor is Reprixys Pharmaceutical Corporation, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01895361 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Alabama.

Frequently Asked Questions

What is clinical trial NCT01895361 about?

NCT01895361 is a clinical study titled "Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises". The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking to...

What is the current status of trial NCT01895361?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 198 participants. The study started on 2013-07. Estimated completion is 2016-03.

What conditions does trial NCT01895361 study?

This clinical trial studies the following conditions: Sickle Cell Disease.

What interventions are being tested in trial NCT01895361?

The interventions under investigation include: Placebo (DRUG), SelG1 (DRUG).

Who is sponsoring clinical trial NCT01895361?

This trial is sponsored by Reprixys Pharmaceutical Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01895361 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.