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Drug Intervention in Chronic Fatigue Syndrome

NCT00848692 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-11

No results posted yet for this study

Summary

Based on pilot patient observations,the investigators anticipate that chronic fatigue syndrome (CFS) patients may benefit from B-cell depletion therapy.

The hypothesis is that at least a subset of CFS patients have an activated immune system involving B-lymphocytes, and that B-cell depletion may alleviate symptoms.

Conditions

  • Chronic Fatigue Syndrome

Interventions

DRUG

Rituximab

Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart

DRUG

Saline (NaCl 0,9 %) (placebo)

Two infusions of saline (NaCl 0,9 %) given two weeks apart

Sponsors & Collaborators

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Olav Mella, MD, PhD · Department of Oncology and Medical Physics, Haukeland University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00848692 on ClinicalTrials.gov