Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)

January 28, 2019 updated by: Symphogen A/S

A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.

This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • Research Site 3203
      • Leuven, Belgium
        • Research Site 3202
      • Yvoir, Belgium
        • Research Site 3201
  • Germany
      • Berlin, Germany
        • Research Site 4906, 4907
      • Duisburg, Germany
        • Research Site 4903
      • Essen, Germany
        • Research Site 4905
      • Halle, Germany
        • Reseach Site 4908
      • Hannover, Germany
        • Research Site 4901
      • Köln, Germany
        • Research Site 4902
      • Regensburg, Germany
        • Research Site 4904
  • India
      • Bangalore, India, 560034
        • St. John's Medical College Hospital, 9106
      • Bangalore, India, 560054
        • MS Ramaiah Memorial Hospital, 9108
      • Bangalore, India, 560099
        • Narayana Hrudayalaya Hospitals, 9105
      • Bangalore, India, 576104
        • Columbia Asia Referral Hospital-Yeshwanthpur, 9101
      • Chennai, India, 600010
        • Aysha Hospital Pvt. Ltd., 9109
      • Hyderabad, India, 500033
        • Apollo Hospital, 9104
      • Udupi, India, 576104
        • Kasturba Medical College Hospital, 9103
  • Israel
      • Haifa, Israel, 31048
        • Bnai-Zion Medical Center, 9721
      • Haifa, Israel, 35254
        • Rambam Medical Center, 9723
      • Holon, Israel, 58100
        • The Edith Wolfson Medical Center, 9725
      • Nahariya, Israel, 22100
        • Western Galilee - Nahariya Hospital, 9722
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center, 9724
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center, 9726
  • Poland
      • Gdansk, Poland
        • Research site 4801
      • Krakow, Poland
        • Research Site 4806
      • Lodz, Poland
        • Research Site 4805
      • Warszava, Poland
        • Research Site 4803
      • Warszawa, Poland
        • Instytut Hematologii i Transfuzjologii, 4807
      • Warszawa, Poland
        • Research Site 4802, 4808
      • Wroclaw, Poland
        • Research Site 4804
  • Romania
      • Brasov, Romania
        • Brasov Country Hospital, 4002
      • Bucuresti, Romania
        • Institutul Clinic Fundeni, 4003
      • Cluj-Napoca, Romania
        • "Prof. Dr. Ion Chiricuta" Oncolgy Institute, 4001
      • Iasi, Romania
        • Spitalul Clinic de Urgente Sfantu Spiridon, 4004
  • Russian Federation
      • Nizhny Novgorod, Russian Federation, 603126
        • Regional Clinical Hospital of Nizhny Novgorod, 7003
      • Samara, Russian Federation, 443095
        • Regional Clinical Hospital na MI Kalinin, 7005
      • St. Petersburg, Russian Federation, 198205
        • Saint Petersburg State Institution Of Healthcare, 7001
      • Tula, Russian Federation, 300053
        • State Healthcare Institution Tula Regional Clin. Hosp., 7002
  • Serbia
      • Nis, Serbia, 18000
        • Clinical Center Nis 3802
      • Novi Sad, Serbia, 2100
        • Clinical center Vojvodina 3801
      • Zemun, Serbia, 11080
        • Clinical Center Zemun 3803
  • Spain
      • Barcelona, Spain
        • Reseach Site 3403
      • Madrid, Spain
        • Hospital Gregorio Maranon, 3405
      • Madrid, Spain
        • Hospital La Princesa, 3404
      • Madrid, Spain
        • Research Site 3401
      • Valencia, Spain
        • Research Site 3402
  • Ukraine
      • Cherkassy, Ukraine, 180009
        • Cherkassy regional oncology center, 3906
      • Donetsk, Ukraine, 83045
        • Gusak Academy of AMS Ukraine, 3905
      • Khmelnytskyi, Ukraine, 29000
        • Khmelnytskyi Regional Hospital, 3903
      • Kiev, Ukraine, 04112
        • City Hospital #9 Kyiv Clinical Hospital, 3904
      • Vinnytsya, Ukraine, 21018
        • Vinnytsya Regional Clinical Hospital, 3902
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • St. James's University Hospital, 4403
      • London, United Kingdom, W12 OHS
        • Hammersmith Hosptial, 4402
      • London, United Kingdom, WC1E 6HX
        • University College, 4401
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmery, 4404
      • Swansea, United Kingdom, SA2 8QL
        • Singleton Hospital, 4405
  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-7680
        • Univ Nebraska Med Ctr. UNMC, 1005
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania, Site 1002
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • 2085 Henry Tecklenburg Drive, 1001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the pre-dose visit.
  • History of isolated ITP
  • RhD-positive serology.
  • Previous treatment and response to first line therapy for ITP

Exclusion Criteria:

  • Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.
  • Suspected infection with HIV, Hepatitis C, H. pylori.
  • Clinical splenomegaly
  • History of abnormal bone marrow examination.
  • Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.
  • Underlying haemolytic condition
  • History of splenectomy.
  • Subject is pregnant, breast feeding or intends to become pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients treated with Sym001
Drug: Sym001
Each cohort will receive one single dose of Sym001 according the assigned dose level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)
Time Frame: 6 weeks post dosing
6 weeks post dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurements of platelet counts
Time Frame: From day 1 through week 6
From day 1 through week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Symphogen A/S

Collaborators

Swedish Orphan Biovitrum

Investigators

  • Principal Investigator: Mario Von Depka Prondzinski, PD Dr., Werlhoff Institut Hannover, Germany
  • Principal Investigator: Ann Janssens, Dr., ZU Gasthuisberg, Leuven, Belgium
  • Principal Investigator: Javier Loscertales Pueyo, Dra, Hospital La Princesa, Madrid, Spain
  • Principal Investigator: Wieslaw Wiktor Jedrzrjczak, Prof., Katedra i klinika Hematologii, Warszawa, Poland
  • Principal Investigator: Andrei Cucucianu, Dr., Prof. Dr. Ion Chiricuta Oncology Institute, Cluj-Napoca, Romania
  • Principal Investigator: Marie Scully, Prof. Dr. MD, University College London Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sym001-03
  • 2007-006081-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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