jwatowatson/primaquine-challenge

Data from a phase 1 study of controlled primaquine induced haemolysis

Primaquine-Challenge

This repository provides data and code for the analysis of a phase 1 healthy volunteer study of primaquine in male thai/burmese G6PD deficient individuals. The study was pre-registered as two separate sub-studies (ascending dose primaquine and single high dose primaquine: Thai Clinical Trial Registry numbers TCTR20170830002 and TCTR20220317004).

The preprint with the clinical results (under review at elife): Pharmacometric assessment of primaquine induced haemolysis in glucose-6-phosphate dehydrogenase deficiency.

We are still working on the paper for the red blood cell modelling results (update of a previous paper in elife: Modelling primaquine-induced haemolysis in G6PD deficiency).

Data and SAP for clinical paper

The are data are provided in the folder Data. The statistical analysis plan is given in the pdf PQ_SAP_v1.pdf.

Main result

The results in the clinical paper are generated in the Markdown Main_analysis.qmd.

The data from the ascending dose study:

The data from the single high dose study:

Modelling work

This is still ongoing. The main models written in stan are in the folder Stan_models.