Treatment of Deficient Subclass or Anti-polysaccharide Antibody Response

NCT00522821 | Completed Phase 4

• 1 other identifier: IUWP2005.01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 9

Brief Summary

There is no consensus on the treatment of patients with recurrent infections and isolated immunoglobulin G (IgG)-subclass deficiency and/or selective antipolysaccharide antibody deficiency. Therefore, the Dutch Inter University Working Party will start a study in which the treatment with antibiotics is compared with intravenous immunoglobulin therapy with respect to clinical outcome measures in both children and adults with this disorder.

Conditions

IgG Deficiency; Infections

Keywords

IgG subclass deficiency; Anti-polysaccharide deficiency; therapy; Immunoglobulins, Intravenous; co-trimoxazole

Outcome Measures

Primary Outcomes (1)

• the number, duration and type of infection (including use of antibiotics to treat infections), days of fever, hospital admissions and, if applicable, days absent from school or work due to infections.

  27 months

Secondary Outcomes (1)

• Safety will be monitored by occurrence of adverse events, vital signs, and laboratory measurements.

  27 months

Study Arms (2)

Antibiotics

OTHER

A: co-trimoxazole prophylactically for 12 months followed by intravenous immunoglobulin treatment for 12 months. Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given.

Drug: intravenous immunoglobulins; Drug: antibiotics

intravenous immunoglobulins

OTHER

B: intravenous immunoglobulin treatment for 12 months followed by co-trimoxazole prophylactically for 12 months. Treatments will be separated by a washout period of 3 months during which co-trimoxazole will be given.

Drug: intravenous immunoglobulins; Drug: antibiotics

Interventions

intravenous immunoglobulins DRUG

* Adults: 600 mg/kg bodyweight every 3 weeks * Children: 800 mg/kg bodyweight every 3 week

Also known as: Nanogam

Antibiotics; intravenous immunoglobulins

antibiotics DRUG

* Children ≥5-12: If well tolerated, 4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily, every day of the week (max160/800mg/day), combined with 5 mg folic acid. * Adults and children ≥12 years or ≥40 kg: If well tolerated, 160 mg trimethoprim and 800 mg sulfamethoxazole once daily, every day of the week combined with 5 mg folic acid.

Also known as: co-trimoxazol, if not lorated: azitromycine

Antibiotics; intravenous immunoglobulins

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IgG subclass deficiency and/or (selective) antipolysaccharide antibody deficiency
• At least 2 physician documented infections before the start of the current treatment or in the last 6 months for newly diagnosed patients.
• Total serum IgG \> 4 g/l
• ≥ 5 years of age
• Informed consent

You may not qualify if:

• Treatment with any other investigational drug within 7 days prior to study entry, or previous enrolment in this study
• Allergic reactions against human plasma/plasma products, or co-trimoxazole
• An ongoing progressive terminal disease
• Pregnancy or lactation
• History of (transient) cerebrovascular accident or coronary insufficiency
• Renal insufficiency (plasma creatinin \> 115 µmol/L; or creatinin clearance \<20 ml/min)
• An ongoing active disease causing general symptoms e.g. chronic active hepatitis or persistent enterovirus infection with ongoing systemic complaints
• Detectable anti-IgA antibodies
• Active systemic lupus erythematosus (SLE)
• Glucose-6-phosphate hydrogenase deficiency

Sponsors & Collaborators

• Prothya Biosolutions: lead

Study Sites (9)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

AMC

Amsterdam, Netherlands

Location

VU

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

LUMC

Leiden, Netherlands

Location

AZM

Maastricht, Netherlands

Location

UMC St Radboud

Nijmegen, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

MeSH Terms

Conditions

IgG Deficiency; Infections

Interventions

Immunoglobulins, Intravenous; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Dysgammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• J T van Dissel, PhD, MD

  LUMC

  PRINCIPAL INVESTIGATOR

• T W Kuijpers, PhD, MD

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

• E AM Sanders, PhD, MD

  UMCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 30, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 6, 2015

Record last verified: 2015-04

Locations

NL (9)