Not recruitingRare disease

Study Comparing Subcutaneous and Intravenous Human Normal Immunoglobulin for New Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is comparing two treatments for CIDP: Hizentra and Privigen. Both treatments contain a substance called human normal immunoglobulin, which is derived from human blood and helps to boost the immune system. Hizentra is given as a subcutaneous injection, meaning it is injected under the skin, while Privigen is administered as an intravenous infusion, meaning it is delivered directly into a vein.

The purpose of the study is to evaluate the effects of these treatments in patients who have not previously received treatment for CIDP. Participants will be randomly assigned to receive either Hizentra or Privigen. The study will last for a total of 26 weeks, during which the effects of the treatments on the participants' symptoms will be monitored. This includes changes in their overall disability, muscle strength, and sensory function. The study will also assess the participants' quality of life, pain levels, and satisfaction with the treatment.

Throughout the study, participants will undergo various tests to measure their progress. These tests include assessments of grip strength, walking ability, and other functional abilities. Blood samples will also be taken to monitor levels of immunoglobulin and other blood components. The study aims to determine which treatment is more effective in managing the symptoms of CIDP and improving the overall well-being of the participants.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of the diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) and an evaluation of the Overall Disability Sum Score (ODSS) to ensure it is greater than 1.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving subcutaneous immunoglobulin (SCIG) and the other receiving intravenous immunoglobulin (IVIG). This process ensures that each participant has an equal chance of being placed in either group.
Step 3
Treatment phase I
The treatment period lasts for 26 weeks. Participants in the SCIG group receive Hizentra 200 mg/ml solution through subcutaneous injection. Participants in the IVIG group receive Privigen 100 mg/ml solution through intravenous infusion. The frequency and dosage are determined by the study protocol and medical team.
Step 4
Monitoring and assessments
Throughout the treatment phase, regular assessments are conducted to monitor changes in the Overall Disability Sum Score (ODSS), muscle strength, sensory parameters, and functional abilities. These assessments include tests such as the 10-meter-walk test, grip strength measurement, and quality of life questionnaires.
Step 5
Treatment phase II
After the initial 26 weeks, participants may continue to receive treatment until the lowest effective dosage of immunoglobulin is reached, up to a maximum of 60 weeks. Adjustments to the treatment plan are made based on individual responses and assessments.
Step 6
Final evaluation
At the end of the study period, a final evaluation is conducted to assess the overall effectiveness of the treatment. This includes a comprehensive review of all collected data and a final measurement of the Overall Disability Sum Score (ODSS).

Who can join the trial?

5 criteria

Patients must be diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which is a condition affecting the nerves.
The diagnosis should meet the criteria set by the European Federation of Neurological Societies and the Peripheral Nerve Society. These criteria help doctors confirm the presence of CIDP.
Patients should be between the ages of 18 and 79 years old.
Patients must have an Overall Disability Sum Score (ODSS) greater than 1. This score is used to measure the level of disability or difficulty in performing daily activities.
Both male and female patients can participate.

Who cannot join the trial?

3 criteria

Patients who have a different condition than Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Aalborg University Hospital
Verified
Aalborg, Denmark
Odense University Hospital
Verified
Odense, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Subcutaneous Immunoglobulin (SCIG)
is a treatment that involves injecting immunoglobulin, a type of protein that helps your immune system fight infections, under the skin. This method allows the medication to be absorbed slowly into the body. In this trial, SCIG is being tested to see how well it works for people who have not been treated before for a condition called chronic inflammatory demyelinating polyneuropathy (CIDP), which affects the nerves and can cause weakness and numbness.
Intravenous Immunoglobulin (IVIG)
is another form of immunoglobulin therapy, but instead of being injected under the skin, it is given directly into a vein. This allows the medication to enter the bloodstream quickly. The trial is comparing IVIG to SCIG to determine which method is more effective for new patients with CIDP over a 26-week treatment period.

Human Normal Immunoglobulin

What is already known about the treatment

Subcutaneous Immunoglobulin (SCIG)
This medication is administered through an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials for its effectiveness in treating chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that affects the nerves. SCIG works by providing antibodies that help modulate the immune system, potentially reducing inflammation and nerve damage. It is classified as an immunoglobulin therapy, which is a type of treatment that uses antibodies to help manage immune system disorders.
Intravenous Immunoglobulin (IVIG)
This medication is given through a vein, known as intravenous administration. It is also being evaluated in clinical trials for its role in treating chronic inflammatory demyelinating polyneuropathy (CIDP). IVIG provides a high dose of antibodies directly into the bloodstream, which can help regulate the immune system and decrease inflammation in the nerves. Like SCIG, it is classified as an immunoglobulin therapy, used to treat various immune-related conditions.

Investigated diseases

Chronic inflammatory demyelinating polyneuropathy (CIDP) – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease progresses slowly, often over several months, and can lead to significant disability if untreated. Symptoms may include tingling or numbness, muscle weakness, loss of deep tendon reflexes, and fatigue. The course of CIDP can vary, with some individuals experiencing periods of improvement and others having a steady progression of symptoms. The exact cause of CIDP is unknown, but it is believed to be an autoimmune disorder.