Prednisone Plus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly

• Register: ClinicalTrials.gov
• Last refreshed on: 23 November 2015
• Main ID: NCT01785979
• Date of registration: 05/02/2013
• Prospective Registration: Yes
• Primary sponsor: Lihir Medical Centre
• Public title: Prednisone Plus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly LiHMS
• Scientific title: Prednisone Plus Chloroquine Versus Chloroquine for the Treatment of Hyper-reactive Malarial Splenomegaly in Papua New Guinea: a Randomized Open-label Trial
• Date of first enrolment: January 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01785979
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Papua New Guinea

Contacts

• Name: Oriol Mitja, PhD
• Affiliation: Lihir Medical Centre

Key inclusion & exclusion criteria

Inclusion Criteria:

- Defining features of HMS including chronic massive splenomegaly (at least 10 cm below
the costal margin); serum Immunoglobulin M elevated more than 3.1 g/L and high
malarial antibody titres (above 640).

- Evidence of the polyclonal nature of the lymphocytes by serum immunoglobulin free
light chains.

- Aged at least 18 years

- Haemoglobin level of > 5 mg/d

Exclusion Criteria:

- known allergy to chloroquine,

- use of anti-malarial treatment within the preceding month,

- suspected coexisting diseases in which glucocorticoids are contraindicated (e.g.
diabetes mellitus, peptic ulcer disease or any acute infection as defined
clinically), and

- splenomegaly secondary to known infectious or haematological causes



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hyper-reactive Malarial Splenomegaly

Malaria

Anaemia

Intervention(s)

Drug: Chloroquine

Drug: prednisone induction - chloroquine

Primary Outcome(s)

composite clinical & immunological endpoint [Time Frame: 12 months]

Secondary Outcome(s)

Bacterial infection [Time Frame: 12 months]

6 months intermediate clinical cure [Time Frame: 6 months]

Anaemia [Time Frame: 12 months]

3 months intermediate clinical cure [Time Frame: 3 months]

Malaria episode [Time Frame: 12 months]

Secondary ID(s)

LiHMS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors