Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies

NCT05702996 | Unknown Phase 3

• 1 other identifier: 2020/0206/HP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.

Conditions

Thrombotic Microangiopathies

Keywords

Eculizumab; gemcitabine

Outcome Measures

Primary Outcomes (1)

• Time from initiation of eculizumab treatment to renal remission

  maximum 12 months

Secondary Outcomes (2)

• Number of AE and SAE during the study

  12 months

• Number of red blood cells transfused before and after treatment with eculizumab

  12 months

Study Arms (1)

Patient with Thrombotic microangiopathies induced by gemcitabine

EXPERIMENTAL

Patient with Thrombotic microangiopathies induced by gemcitabine will be treat with Eculizumab

Drug: Eculizumab administration

Interventions

Eculizumab administration DRUG

Patient with Thrombotic microangiopathies induced by gemcitabine will be treat with Eculizumab

Patient with Thrombotic microangiopathies induced by gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years old 2. Previous treatment with gemcitabine within the last 18 months (duration of treatment ≥ 3 consecutive months and cumulative dose should be ≥ 10 grams). 3. Neoplasia in remission or not in remission but with an estimated life expectancy \> 6 months 4. Acute renal failure defined by 1 of the following 2 criteria : Creatinine \> 2 times baseline creatinine and/or diuresis \< 0.5 ml/kg/h for 12 hours. 5. Clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tThrombocytopeniaPatient affiliated with a social security system, 6. Adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form. 7. Woman of childbearing age with effective contraception as defined by the WHO (estrogen-progestin or intrauterine device or tubal ligation) for more than one month and a negative -HCG pregnancy test at baseline, for the duration of the study and for at least 5 months after the end of the treatment, or Postmenopausal woman (non-medically induced amenorrhea for at least 12 months prior to the baseline visit) or For men, use of protection during sexual intercourse for the duration of the study and for at least 60 days after the end of study treatment

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (2)

Amiens University Hospital

Amiens, France

Location

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Thrombotic Microangiopathies

Condition Hierarchy (Ancestors)

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Steven GRANGE, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven GRANGE, MD

CONTACT

+3323288; steven.grange@chu-rouen.fr

Florian VALLIN

CONTACT

+3323288; florian.vallin@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: March 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)