Phase 3 study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP)

Open-label, uncontrolled, before-and-after study of GGS in chronic inflammatory demyelinating polyneuropathy (CIDP) (Phase 3 study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222421

Enrollment

Registered

2014-03-13

Start date

2014-03-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic inflammatory demyelinating polyneuropathy(CIDP)

Interventions

investigational material(s) Generic name etc : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS) INN of investigational material : - Therapeutic category code : 634 Human blood preparations Do

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with Chronic inflammatory demyelinating polyneuropathy(CIDP) Main Inclusion Criteria 1.Patients considered to have definite or probable CIDP as defined in the diagnostic criteria by the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Task Force before the time of providing informed consent 2.Patients who have disability with a total score of 2 or more and 9 or less according to the Inflammatory Neuropathy Cause and Treatment Overall Disability Sum Scale (INCAT)

Exclusion criteria

Exclusion criteria: Main Exclusion Criteria 1. Patients with a history of shock or hypersensitivity to any human immunoglobulin preparation 2. Patients with IgA deficiency 3. Patients with hemolytic/blood loss anemia 4. Patients with reduced cardiac function 5. Patients with end-stage renal disease 6. Patients with cerebrovascular or cardiovascular disorder 7. Patients with a high risk of thromboembolism 8. Patients with immunodeficiency or under immunosuppression 9. Pregnant, potentially pregnant, or lactating patients 10. Patients who are being treated in other clinical study

Design outcomes

Primary

Measure	Time frame
efficacy Primary endopoint Muscle strength Evaluation method Inflammatory Neuropathy Cause and Treatment Overall Disability Sum Scale (INCAT)	—

Secondary

Measure	Time frame
safety efficacy Main secondary endpoints Efficacy Neuropathy Evaluation method MRC sum score, Grip strength, ISS score, Electrophysiological test Safety Adverse events, Vital signs, Clinical laboratory tests	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026