Romiplostim in Treating Hepatitis C-Infected Patients With Thrombocytopenia

What Was Tested

In this phase 2 trial, researchers set out to test Romiplostim.

RATIONALE: Romiplostim may cause the body to make platelets.

PURPOSE: This randomized phase II trial is studying how well romiplostim works in treating hepatitis C-infected patients with thrombocytopenia.

It had two arms (groups): Arm I (active comparator) and Arm II (placebo comparator).

Patients receive romiplostim subcutaneously once weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive placebo subcutaneously once weekly for 8 weeks. Patients failing to achieve a platelet count of \> 100,000/L cross over to arm I.

The registry classes the interventions as biological, drug and other.

More on the Plan

To assess the platelet count response to administration of weekly romiplostim patients with HCV infection whose initial platelet count is \< 70,000/L.

To assess the safety and tolerability of romiplostim the treatment of patients with HCV infection and thrombocytopenia; including physical symptoms and findings, hematologic, serum chemistries and liver function tests and adverse events.

To assess the ability of romiplostim to enable subjects to achieve a platelet count sufficient to start antiviral therapy.

To assess the ability of romiplostim to maintain platelet counts greater than 50,000/L while receiving antiviral therapy with pegylated interferon and ribavirin.

Who Took Part

The registry lists 27 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Liver biopsy indicating chronic hepatitis within the previous 2 years. Mean platelet count of \< 70,000/L on two repeated measurements in a two week screening period with no single count \>= 75,000/L. Neutrophil count of \>= 1000/mcl. Hemoglobin \>= 11gm/dL and no evidence of active bleeding. Prothrombin Time (PT) INR \< 1.6 seconds.

The full record lists 26 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, crossover and double-blind.

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Romiplostim and the comparison at some point, usually with a gap in between.

As a double-blind Romiplostim study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2010-06-30 with completion listed for 2014-07-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean platelet count for actively treated and placebo treated subjects (time frame: Weeks 6-8).

It also tracked 5 secondary outcomes, for example Number of subjects in each treatment group who achieve a platelet count of greater or equal to 100,000/L, Changes in plasma HCV viral load during treatment with romiplostim alone and Incidence of sustained viral response achieved during treatment with anti-viral therapy in combination with romiplostim.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Romiplostim in 27 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.