Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis (He-ppi)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Annadal stichting
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01524757
First received: January 31, 2012
Last updated: February 1, 2012
Last verified: January 2012
  Purpose

Hereditary Hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload causing damage of different important organs like heart, liver, pancreas and joints. Complications and symptoms can regress by intensive treatment reducing the iron overload stores.Different genes have been identified playing a role in the pathophysiology of iron overload. A clinically important HFE gene mutation is the C282Y, located on chromosome 6. Phlebotomy is currently the standard therapy which consists of removal of 500 ml whole blood weekly, representing a loss of 250 mg iron. In naive patients between 20 to 100 phlebotomies are required to reduce the serum ferritine levels to 50 μg/L. Thereafter, a lifelong maintenance therapy of 3 to 6 phlebotomies yearly is needed.

For absorption, dietary iron ( 70%) is reduced by gastric acid form the ferric (Fe3+) to the ferrous form (Fe2+). Recently, in an observational open study, Hutchinson et al. found that HH patients treated with proton pump inhibitors (PPI) needed fewer phlebotomies, resulting in a drop of 2.5 (SEM 0.25) to 0.5 (SEM 0.25) liter per year.

Research question: The primary objective is to determine the effectiveness and cost effectiveness of PPI's compared to standard phlebotomy therapy in the prevention of iron overload in HH patients.

Multi-center trial in two hospitals in the South of Limburg (Atrium medical Center, Maastricht university medical center ) and hospital in Belgium (University Hospital Gasthuisberg). The study will be conducted in randomised double blind manner. The follow up will be one year.

Patients are randomized either for the group receiving a PPI or a placebo. Every 2 month the ferritin level is measured and decided if the patient need a phlebotomy (Ferritin >100 µg/L).


Condition Intervention
Hemochromatosis
Drug: Pantoprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proton Pump Inhibitors in the Prevention of Iron Reaccumulation in Patient With Hereditary Hemochromatosis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • the total number of phlebotomies for the group taking PPI treatment compared to the group taking placebo will be the primary endpoint of the study. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • number of participants with side effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: March 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pantoprazol Drug: Pantoprazole
pantoprazole 40mg 1dd1; 12 months
Placebo Comparator: placebo Drug: Pantoprazole
pantoprazole 40mg 1dd1; 12 months

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hereditary hemochromatosis (HH), homozygous for C282Y, currently treated with phlebotomy as maintenance therapy for at least 12 months with ≥ 3 phlebotomies per year.
  • Ferritin level between 50-100 μg/L at start of the inclusion.
  • Age: 18 years- 60 years and weight > 50 kg.

Exclusion Criteria:

  • Patients receiving other therapies such as chelating therapy or forced dietary regimen.
  • Patients younger than 18 years.
  • HH patients with excessive overweight (BMI > 35).
  • Patients who are mentally incapacitated.
  • Women being pregnant or expecting/ planning to become pregnant during the one year period of the study.
  • Patients with a malignancy.
  • Patients already on PPI treatment.
  • Patients who experienced side effects of PPI's.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524757

Contacts
Contact: G Koek, dr +31-43-3875021 gh.koek@mumc.nl
Contact: C Deursen Van, dr 31-45-5279639 c.vandeursen@atriummc.nl

Locations
Belgium
University hospital Gasthuisberg Not yet recruiting
Leuven, Limburg, Belgium, 3000
Contact: David Cassiman, prof. dr.    +32 16344626    david.cassiman@uzleuven.be   
Principal Investigator: David Cassiman, prof. dr.         
Netherlands
Atrium MC Parkstad Not yet recruiting
Heerlen, Limburg, Netherlands, 6440 AG
Contact: Cees Deursen, dr    +31-45-5279639    c.vandeursen@atriummc.nl   
Contact: Reggy Jaspers, drs    +31-43-3875021    r.jaspers@Mumc.nl   
Principal Investigator: C Deursen, dr         
Maastricht university medical center Not yet recruiting
Maastricht, Limburg, Netherlands, 6202AZ
Contact: Reggy Jaspers, drs    +31-43-3875021    r.jaspers@mumc.nl   
Contact: Ger Koek, dr-    +31-43-3875021    gh.koek@mumc.nl   
Principal Investigator: Ger Koek, dr         
Sponsors and Collaborators
Maastricht University Medical Center
Annadal stichting
Investigators
Principal Investigator: G Koek, Dr Maastricht University Medical Center
  More Information

Publications:

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01524757     History of Changes
Other Study ID Numbers: NL3364409612
Study First Received: January 31, 2012
Last Updated: February 1, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Hemochromatosis
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Proton Pump Inhibitors
Pantoprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014