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Ulcerative ColitisNCT00781638

ADAPT Adacolumn Pediatric Trial in Ulcerative Colitis

A study testing Adacolumn® in people with Ulcerative Colitis, run by Otsuka Frankfurt Research Institute GmbH.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is PUCAI at Week 12. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Adacolumn®
Type of treatment
Medical device
How many people
24 participants
Where
No sites listed yet
Study dates
Oct 2008to Mar 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children and adolescents < 18 years
  • Ulcerative colitis documented by clinical symptoms, endoscopic findings and histology (in patient history)
  • Moderate active ulcerative colitis at baseline evaluation, defined as follows:PUCAI between 35 and 64
  • Pancolitis or left-sided colitis
  • Ulcerative colitis for at least 3 months
  • Receiving or having received one or more of the following medicinal products before screening:
Show all 14Show fewer
  • Sulfasalazine, mesalamine and other 5-aminosalicylic acid (5-ASA) agents for 4 weeks or more with a stable dose for the last 2 weeks,
  • 0.5mg/kg/body weight with a maximum of 20 mg per day of prednisone with a stable dose for the last 2 weeks, or
  • 6-mercaptopurine or azathioprine for 12 weeks or more with a stable dose for the last 4 weeks Other UC medication is not allowed (see also Chapter 4.4.2).
  • For female patients of child-bearing potential, a negative pregnancy test and agreement to use an effective contraceptive method or abstain from sexual activities during the course of the clinical investigation
  • Agreement to participate in all visits
  • Signed written informed consent document by patients and their legal guardian or representative
  • Body weight must be more or equal 30kg
  • Adequate peripheral venous access to allow for completion of the apheresis treatments

Who cannot join

  • Febrile (>38ºC)
  • Evidence of toxic megacolon
  • Anticipated need for surgery within 12 weeks after Day 00
  • Major surgery within the past 6 weeks
  • Known obstructive diseases of the gastrointestinal system
  • Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
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  • A history of allergic reaction to heparin or heparin-induced thrombocytopenia
  • A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
  • Known infection with enteric pathogens, pathogenic ova or parasites, or a positive assay for C. difficile toxin
  • Symptomatic hypotension
  • Pediatric heart conditions and problems at high susceptibility for thrombotic events (e.g. valve defects or similar)
  • A history of physical findings compatible with a cerebrovascular accident
  • Prosthetic heart valve, pacemaker or other permanent implant
  • Severe cardiovascular or peripheral vascular disease
  • Liver disease defined as levels of GOT [AST], GPT [ALT] or alkaline phosphatase >2.5x the upper limit of the normal range for the laboratory performing test
  • History of cirrhosis
  • Renal insufficiency, defined as serum creatinine >150% of the upper limit of the normal range for the laboratory performing the test
  • Known bleeding disorder (PT or PTT>1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
  • Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
  • Known infection with Hepatitis B or C, or HIV
  • Abnormal hematology parameters defined as severe anemia with hemoglobin <8.5g/dL, white blood cell count of <3,500/μl and a granulocyte count <2,000/μl
  • Fibrinogen level >700mg/dL
  • Infection:
  • Active infections from successful completion of antibiotic treatment for routine bacterial infection less than 4 weeks of entry into the clinical investigation (screening)
  • Febrile viral infection within 4 weeks of entry into the clinical investigation (screening)
  • Less than 12 weeks from conclusion of therapy for systemic fungal infections to screening
  • Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
  • History of dysplasia or carcinoma of the colon
  • Current drug or alcohol abuse
  • Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
  • Used within the last 30 days an investigational medicinal product, biologic or device
  • Pre-treatment of UC with drugs other than 5-ASA and derivatives, azathioprine and or corticosteroids, e.g. immunosuppressants and biologics
  • Steroid-resistance or -dependency, defined as inability to completely withdraw steroids without inducing a relapse or flare-up of the disease
  • Topical therapy for ulcerative colitis within the last 2 weeks.

About this study

Official title: Open Uncontrolled Investigation to Assess the Efficacy and Safety of Adacolumn® Granulocytes, Monocytes / Macrophage Apheresis Device in Children and Adolescents With Active Ulcerative Colitis

Children aged up to 18 years with moderately active Ulcerative Colitis (PUCAI:35-64) will receive one weekly Adacolumn® apheresis treatment over 5 consecutive weeks, followed by up to 3 optional Adacolumn® apheresis treatments over 3 consecutive weeks. Primary end point is PUCAI at Week 12.

The main part of the clinical investigation will be continued by a one year follow up for responders.

Read the detailed description

The individual clinical investigation period will be 12 weeks per patient. If the patient will take part in the follow up, the individual clinical investigation period will be 64 weeks.

Patients receive one weekly Adacolumn® apheresis over 5 consecutive weeks. The treating investigator may decide to add up to 3 treatments based on his judgment.

Treatment details Day -07: Screening; Day 00 Baseline: 1st Adacolumn® apheresis; Day 07: 2nd Adacolumn® apheresis; Day 14: 3rd Adacolumn® apheresis; Day 21: 4th Adacolumn® apheresis; Day 28: 5th Adacolumn® apheresis; Week 12:Final evaluation

Being tested
Adacolumn®
Keywords
Pediatric UC, Adacolumn apheresis
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adacolumn®Device

    Also called GMA apheresis (Granulocytes/Monocytes adsorptive apheresis).

    The medical device Adacolumn® (CE-Mark Certificate G1 07 01 366 76013) is an adsorptive type extracorporeal apheresis column. It has been shown to effectively improve clinical and endoscopic signs and symptoms in UC in adults by removing granulocytes and monocytes and by changing the Cytokine production.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary response variable: Changes in mean PUCAI between baseline and Week 12

    Measured: 12 Weeks plus 1 year Follow up

Secondary outcomes (1)

  1. Difference in Endoscopic Activity Index (EAI) according to Rachmilewitz between Week 12 and baseline for those patients with 2 endoscopies

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00781638
Sponsor's protocol ID
Ada-UC-08-101
Status last verified
Apr 2012
First submitted
28 Oct 2008
Last updated
3 Apr 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Adacolumn® in people with Ulcerative Colitis, run by Otsuka Frankfurt Research Institute GmbH.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary response variable: Changes in mean PUCAI between baseline and Week 12 (time frame: 12 Weeks plus 1 year Follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00781638.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2012.

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